Line Manager (Improvement)

Supervisor III Materials Planning

Sales Manager – Device Business (South Zone)

Sales Manager – Device Business (East Zone)

Technical Support Specialist

PVD Equipment Engineer

Manager, Analytical Quality Assurance

Exports Manager APAC

Facilities & Utilities Manager

Site Investigation Lead, Quality Assurance

Responsibilities: <ul><li>Responsible for building capabilities through the deployment of the AM COE to enable standard process standards to be embedded and drive improved and sustainable operational results within the site.&nbsp;</li><li>Facilitate monthly performance AM CoE review with the site AM CoE members.&nbsp;</li><li>Participate in monthly KWS call with the Regional Lead of AM CoE.</li><li>Lead governance process to ensure the effective delivery of the AM program and activities.</li><li>Actively engage with the Regional CoE lead to devise strategy and execution of existing and future AM CoE Phase development and deployment.</li><li>Ensure the use of AM tools are being adopted to drive business process excellence and deliver business results, while developing, training, and supporting cross functional teams across the site on AM tools.</li><li>Support the implementation of Digitalization on AM apps at site level.&nbsp;</li><li>Provide training on AM CoE tools.&nbsp;</li><li>Set targets and ensure key performance metrics are available to be published for AM, updating key stakeholders on a regular basis, escalating issues accordingly to the appropriate channels.&nbsp;</li><li>Ensures the use of best practices and applies lessons learned from previous projects; shares lessons learned with other project management team members. Prove linkage of key performance indicators to business process effectiveness. Document and institutionalize controls.&nbsp;</li><li>Responsible for supporting the execution of relevant projects within assigned area / shift.</li><li>Responsible for monitoring, analysis and keeping the control of the process for the line by strict monitoring and variation analysis of the production plan.</li><li>Ensures that the personnel comply with Safety and Food Safety regulatory requirements throughout their lines.</li><li>Accountable for participating in the Safety Seven program by performing the Gemba walks while ensuring that operations personnel comply with all the policies, programs and activities focused on preventing injuries, sickness and environmental sustainability. All this, through safe behaviors, K-Value alignment and the belief that all injuries are preventable.</li><li>Accountable for participating &amp; close on the identified actions from the Gemba walks (Golden Six) and participates in the scheduled walks.</li><li>Responsible for complying with good manufacturing practices. If a food safety variation is identified, this person is responsible for final reporting together with Line Manager and following up on corrective actions after agreement with relevant department such as QA, Engineering &amp; Technical team.</li><li>Ensures the implementation and follow up of actions resulting from root cause analysis, enabling problem-solution sessions related to the equipment and continuous improvement.</li><li>Active participation, analyses &amp; understand with other COE’s, all the line shutdowns, variations, OEE Trends, waste and generates action to avoid them.</li><li>Leads improvement projects for the line oriented to generate savings and increase productivity to directly impact the OEE and comply with the plant savings pipeline.</li><li>Responsible for giving weekly and monthly visibility of all activities related to their line by giving service needs for their lines, therefore job planned accordingly.</li><li>Ensures compliance with the company Work Systems (KWS) culture across all Supply Chain functions to enhance ways of working driving towards being KWS compliant Manufacturing Plant.</li><li>Responsible for managing the operation team (HR process): vacation, absence, leaves, extra hours, as well as execution of disciplinary actions.</li><li>Ensures the technical and leadership competency development of their Shift Managers &amp; development of the operative personnel.</li><li>Maintains high motivation, productivity and work environment levels among the production personnel by establishing and keeping permanent contact and good communication to identify their needs and concerns.</li><li>Other duties as assigned.</li></ul> Requirements: <ul><li>This position requires the applicant who is tertiary educated in a manufacturing or other supply chain operations discipline.</li><li>Demonstrated ability to manage complexity coupled with strong problem solving, negotiating, and decision-making skills.</li><li>Strong knowledge of manufacturing within a FMCG operation.</li><li>Experience in implementing lean manufacturing techniques., AM, continues improvements tools in processes.</li><li>Strong people management is required coupled with the ability to work cross functionally across the organization.&nbsp;</li><li>Able to communicate and influence at all levels of the organization.</li></ul>

Responsibilities: <ul><li>Guarantee the application of planning and control policies of the supply chain focused on efficiency and service level.</li><li>Coordinate and verify the compliance of areas that comprise the supply chain (planning and purchasing).</li><li>Lead the area and implement the development of new innovation processes within the operation and practice of the supply chain.</li><li>Attend internal and external audits of the area.</li><li>Establish controls and improvements to achieve high inventory reliability.</li><li>Recruit and train the appropriate personnel for the different positions in the department.</li><li>Ensures compliance in responsibilities, hiring, training and performance evaluation and professional development of assigned employees with an action plan to improve performance and motivation of the team.</li><li>Achievement of goals established by the organization.</li></ul> Daily activities: <ul><li>Ensure internal sourcing and delivery of products to customers on time and with the required quality.</li><li>Oversee planning and purchasing processes.</li><li>Periodic activities:</li><li>Review ERP parameters and information to ensure optimal performance.</li><li>Review and analyze current demand vs. Forecast</li><li>Projection of loads and capacities for production.</li><li>Eventual activities:</li><li>Transfers (line or equipment migrations)</li><li>Quality audits</li><li>Participation and follow up in assigned continuous improvement projects.</li></ul> Requirements: <ul><li>Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field; or equivalent practical experience.</li><li>At least 5+ years’ experience in RPA development or automation solutions design.</li><li>UI Path certification is highly desirable.</li><li>Proficiency in RPA tools such as UI Path, Power Automate, PowerApps and familiarity with other platforms like Blue Prism or Automation Anywhere.</li><li>Strong programming skills in Python, Selenium etc with experience in developing automation scripts and API integrations.&nbsp;</li></ul>

Responsibilities: <ul><li>Develop and implement zonal sales strategies aligned with national goals.</li><li>Monitor sales performance and ensure monthly / quarterly / yearly sales target is achieved.</li><li>To work closely with employees of dealers to generate leads, ensure demonstration of devices and close sales.</li><li>Establish dealers’ infrastructure to drive the business in private and government sectors.</li><li>Build and maintain strong relationships with dealers and key accounts.</li><li>To conduct regular field visits for developing KOLs, identify new market opportunities, engaging with key customers (hospitals, clinics, healthcare professionals) to build long-term relationships.</li><li>Plan, coordinate, and execute the zonal rollout of newly launched medical devices.</li><li>Collaborate with the marketing team to ensure effective market introduction .</li><li>Conduct training programs for internal sales teams and channel partners on new product features, benefits, and usage.</li><li>Track performance of new products post-launch and provide feedback to marketing.</li><li>Medical devices portfolio includes Point of Care Ultrasound device from Butterfly. We also plan to expand this portfolio to include Butterfly Vet, along&nbsp;</li><li>With future offerings in the Cardiology, Neurology, and Gynaecology segments.</li></ul> Requirements: <ul><li>Minimum Graduate with Science Background preferably.</li><li>Expertise on consultative selling.</li><li>Ready to cover and manage large Geographies.</li><li>Professional driven by values and science.</li><li>Knows the business development process.</li><li>Aspire to learn and discuss new technologies</li><li>Ready to take the challenges for establishing new products and technologies.</li><li>The person should have a minimum of 12 to 14 years of experience working in the medical device industry in the South Zone handling capital equipment.</li><li>Preferably from Critical care, intensive care, anesthesia, Cardiology background.</li></ul>

Responsibilities: <ul><li>Develop and implement zonal sales strategies aligned with national goals.</li><li>Monitor sales performance and ensure monthly / quarterly / yearly sales target is achieved.</li><li>To work closely with employees of dealers to generate leads, ensure demonstration of devices and close sales.</li><li>Establish dealers’ infrastructure to drive the business in private and government sectors.</li><li>Build and maintain strong relationships with dealers and key accounts.</li><li>To conduct regular field visits for developing KOLs, identify new market opportunities, engaging with key customers (hospitals, clinics, healthcare professionals) to build long-term relationships.</li><li>Plan, coordinate, and execute the zonal rollout of newly launched medical devices.</li><li>Collaborate with the marketing team to ensure effective market introduction.</li><li>Conduct training programs for internal sales teams and channel partners on new product features, benefits, company</li><li>Track performance of new products post-launch and provide feedback to marketing.</li><li>Medical devices portfolio includes Point of Care Ultrasound device from Butterfly. We also plan to expand this portfolio to include Butterfly Vet, along with future offerings in the Cardiology, Neurology, and Gynaecology segments.</li></ul> Requirements: <ul><li>Minimum Graduate with Science Background preferably.</li><li>Expertise on consultative selling.</li><li>Ready to cover and manage large Geographies.</li><li>Professional driven by values and science.</li><li>Knows the business development process.</li><li>Aspire to learn and discuss new technologies</li><li>Ready to take the challenges for establishing new products and technologies.</li><li>The person should have a minimum of 12 to 14 years of experience working in the medical device industry in the East Zone handling capital equipment.</li><li>Preferably from Critical care, intensive care, anesthesia, Cardiology background</li></ul>

Brookfield Culture
Brookfield has a unique and dynamic culture.  We seek team members who have a long-term focus and whose values align with our Attributes of a Brookfield Leader:  Entrepreneurial, Collaborative and Disciplined.  Brookfield is committed to the development of our people through challenging work assignments and exposure to diverse businesses.
Job Description 
Technology Services (TS) is responsible for delivering all enterprise infrastructure, applications and related end user technology services across all Brookfield business groups, comprised of approximately 6,500 users. The Deskside Technician is the face of Technology Services, providing first-line support to end users. 
The Technical Support Specialist will report to the Team lead, Deskside.  In addition to incident logging, resolution, and ownership, the Deskside Technician will collaborate with team members and other Technology Services teams to maintain and improve the end user experience of all Brookfield users. 
The ideal candidate for this role will possess the following attributes.
•	Accountability – candidate has a sense of ownership when troubleshooting a problem and will see things through to completion.
•	Professionalism - candidate maintains composure and integrity while providing timely support to end users.  
•	Detail Oriented – candidate takes the time to listen and understand the issue and works with the appropriate teams to resolve. 

Responsibilities:
•	Provides exceptional deskside and remote support to Brookfield users.
•	Owns and follows up on IT support requests and problem tickets until user confirms resolution. 
•	Provides installation, configuration, maintenance and troubleshooting support of computer hardware, software, audio/visual, networks, printers, and computer peripherals.
•	Provides technical training to end users. 
•	Ensures past incidents and resolutions are documented appropriately according to knowledge management standards. 
•	Positively represents Brookfield Technology Services with professionalism in all interactions. 
•	Proactively follows up on IT service requests/IT problem tickets until customer confirms resolution.
•	Collaborates with other team members to provide efficient, full-service support. 
•	Participates in testing new desktop technologies and software. 
•	Technician must maintain professionalism, good attitude and appropriate behavior with all users and vendors.
•	Technician will provide customer technical education, and support high level technical problems.
•	Assists, encourages, and serves as a backup to other team members.
Technical Skills
Knowledge of the following:
•	ITIL Methodology
•	Proficient with the following technologies: 
o	Windows 10 & 11, 
o	Microsoft Office (O365)
o	Internet Browsers, 
o	Local Account Management, 
o	Installs and removals, Registry, Command line, Service management systems and System Management Tools,
o	MFA (Microsoft Authentication)
o	VPNs
•	Proficient with the following hardware:
o	Desktop / Laptop
o	iPad/iPhone, 
o	Android Phones/Devices 
o	Printers
o	Cisco Video Conferencing equipment, 
o	Teams phones
•	Knowledge of wide area networks (SDWAN), TCP/IP, and Server OS is desired.
Experience
•	5+ years of related experience
•	Bachelor’s degree in computer science, business computing, or a related field, or equivalent combination of education, certification, and experience.
•	Preferred experience with financial services, with front office support a plus
•	Experience in a related role requiring, timeliness, customer service, organization, prioritization, troubleshooting, and working independently to successfully install, configure, maintain, and support Windows and/or Mac desktop operating systems and software.
•	Strong and effective customer relationship management skills and process/practice experience
•	Experience working with third-party service provider service delivery execution and business governance.
•	Experience with ServiceNow ticketing system preferred, but not required.
•	Understands the importance and is vigilant with Cybersecurity matters.



Responsibilities:
•	Provides exceptional deskside and remote support to Brookfield users.
•	Owns and follows up on IT support requests and problem tickets until user confirms resolution. 
•	Provides installation, configuration, maintenance and troubleshooting support of computer hardware, software, audio/visual, networks, printers, and computer peripherals.
•	Provides technical training to end users. 
•	Ensures past incidents and resolutions are documented appropriately according to knowledge management standards. 
•	Positively represents Brookfield Technology Services with professionalism in all interactions. 
•	Proactively follows up on IT service requests/IT problem tickets until customer confirms resolution.
•	Collaborates with other team members to provide efficient, full-service support. 
•	Participates in testing new desktop technologies and software. 
•	Technician must maintain professionalism, good attitude and appropriate behavior with all users and vendors.
•	Technician will provide customer technical education, and support high level technical problems.
•	Assists, encourages, and serves as a backup to other team members.


Responsibilities: <ul><li>Perform equipment troubleshooting with systematic &amp; analytical mindset to minimize/eliminate downtime</li><li>Oversees decommissioning, movement, installation, upgrade, retrofit &amp; maintenance of manufacturing equipment</li><li>Monitors equipment uptime &amp; implement relevant improvement actions to improve equipment reliability &amp; solve chronic issues</li><li>Conduct training for line technicians to improve their technical competency and fan out critical knowledge relevant to achieve key departmental KPIs</li><li>Manage spare part cost &amp; availability</li><li>Collaborate with process engineers on yield related topics and implement relevant improvement/containment actions to prevent recurrence</li><li>Collaborate with external vendors on equipment troubleshooting, spare part availability/procurement &amp; equipment upgrade/retrofit</li><li>Participate or lead projects involving downtime reduction, cost saving, yield improvement or new material qualification.</li><li>Defines maintenance procedures &amp; upkeep documents related to the smooth running of manufacturing equipment</li><li>Coordinates equipment activities with inter and intra department personnel to ensure smooth execution</li></ul> Requirements: <ul><li>Bachelors degree in Computer Science, Electrical/Electronics Engineering, Engineering, or related field.</li><li>Hands on individual with experience in vacuum PVD equipments.&nbsp;</li><li>Dynamic team player who possesses good interpersonal skills</li><li>Strong passion &amp; drive to seek improvements to equipment &amp; process setup</li></ul>

Responsibilities: Accountability AQA Management <ul><li>Manage all Analytical and Quality Control (QC) activities to ensure compliance with cGMP, FDA, EMA, and ICH guidelines.</li><li>Lead a team of data reviewers, ensuring accurate, complete, and timely review of raw data, analytical results, and laboratory documentation.</li><li>Supervise the Stability Program and Coordinator, including protocol approval, sample pull scheduling, data review, and reporting.</li><li>Ensure analytical data integrity through implementation and oversight of robust review processes and audit trails.</li><li>Collaborate with QC, QA, and R&amp;D departments to support method validations, transfers, and investigations.</li><li>Review and approve analytical documentation such as CoAs, method validation/verification protocols and reports, and stability summaries.</li><li>Lead or support investigations into out-of-specification (OOS), out-of-trend (OOT), deviations, and laboratory incidents.</li><li>Support regulatory inspections and internal/external audits, providing documentation and subject matter expertise.</li><li>Drive continuous improvement initiatives in QA/QC processes and systems to ensure operational excellence and regulatory readiness.</li><li>Mentor, coach, and develop the AQA team to build a high-performing quality organization.</li></ul> Workload Management <ul><li>Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> SOPs <ul><li>Review/Approve SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li></ul> Staff Development <ul><li>Evaluate potential candidates for QA, performance evaluation of direct reports.</li><li>Coordinate data review for analytical tests, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing.</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field (master’s or Ph.D. preferred).</li><li>Minimum of 10 years of experience in pharmaceutical analytical quality assurance or quality control.</li><li>Proven leadership or supervisory experience in a GMP-regulated environment.</li><li>Experience with analytical instrumentation (HPLC, GC, UV, IR, etc.) and associated data review.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills..</li></ul> Knowledge <ul><li>Strong understanding of FDA regulations, cGMP, ICH guidelines, USP/EP compendia.</li><li>Knowledge of pharmaceutical manufacturing processes and laboratory practices.</li><li>Familiarity with regulatory submission requirements (ANDA, NDA, etc.).</li><li>Proficiency with laboratory software and documentation systems (e.g., Empower, LIMS, TrackWise).</li></ul> Skills &amp; Abilities <ul><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills.</li><li>Strong attention to detail with a commitment to quality and compliance.</li><li>Effective leadership, team management, and interpersonal communication.</li><li>Ability to prioritize and manage multiple tasks in a fast-paced environment.</li><li>Proficient in technical writing and reviewing complex data and reports.</li></ul> Physical Requirements <ul><li>Ability to sit or stand for extended periods.</li><li>Occasionally lift up to 25 pounds.</li><li>Use of personal protective equipment (PPE) as required in laboratory or production areas.</li><li>Ability to work in office, laboratory, and manufacturing settings as needed.</li><li>The work environment is representative of a group laboratory environment.</li></ul>

Responsibilities: <ul><li>Manage and expand the distributor network, driving new business growth and market penetration</li><li>Provide sales training, technical guidance, and commercial strategy support to distributors</li><li>Conduct business reviews and performance evaluations, ensuring revenue targets are met</li><li>Implement structured sales processes and best practices to optimize distributor performance</li><li>Define and execute a regional sales strategy to maximize growth opportunities</li><li>Analyze market trends, distributor performance, and competitive landscape to inform business decisions</li><li>Act as a strategic advisor to distributors, ensuring alignment with commercial objectives</li><li>Build and maintain business relationships with key accounts, industry leaders, and stakeholders in medtech and clinical diagnostics</li><li>Lead new product launches, ensuring distributors are trained and aligned with go-to-market strategies</li><li>Develop and execute regional marketing and sales campaigns in collaboration with distributor partners</li><li>Represent the company at industry events, conferences, and customer meetings to strengthen market presence.</li></ul> Requirements: <ul><li>6+ years managing distributors across APAC - ideally in Indochina, South Asia &amp; Bangladesh</li><li>Graduation with MBA&nbsp;</li><li>Experience in the medtech industry, or clinical diagnostics</li><li>Proven success in equipment sales and value selling</li><li>Experience in complex sales processes, handling multiple stakeholders</li><li>Background in GMP sales is a plus</li><li>Excellent commercial and technical communication skills, both verbal and written</li><li>Ability to tailor messaging for diverse audiences, from product managers to C-level executives</li><li>Multicultural business management with the ability to navigate diverse distributor dynamics.</li><li>Highly structured, strategic, and results-driven, with sales methodology</li><li>Self-driven, proactive, entrepreneurial, thriving in an independent role with full business ownership.</li><li>Confident in high-level sales pitches and executive engagement</li><li>Leadership and coaching skills, capable of training and developing distributor sales teams</li><li>Passionate about scientific, technical, and commercial excellence</li><li>Ability to travel</li></ul>

Responsibilities: <ul><li>Lead KWS RM COE and own equipment criticality element as part of the facilities and utilities operation.</li><li>Lead Facilities &amp; Utilities team insourcing maintenance strategy with a strong technical development plan</li><li>Delivery highest level of facilities and utilities machine reliability with the optimum level of preventive, corrective &amp; condition-based base maintenance strategic formulation and implementation.</li><li>Lead and implement integrated facilities management for factory-wide facilities management/maintenance. This includes the hard and soft service of the facilities management.&nbsp;</li><li>Key member and element owner of Technical COE on FUS and drive all global FUS programs.</li><li>Key member of NRC COE to drive sustainability agenda through out the factory.</li><li>Develop good relationships with other regional factories and strive for cross-learning and implementation of best practices for plant performance and KWS.</li><li>Owns engineering facilities and utilities R&amp;M cost budgeting and end-to-end management and monitoring.&nbsp;</li><li>Conducts effective cost reduction initiatives in line with ZLA &amp; KIMMS projects.&nbsp;&nbsp;</li><li>Leads ongoing cross-functional teams to conduct analyses of plant savings opportunities, identify CAPEX investment opportunities, and make strategic investments to support growth and machine reliability.</li><li>Provide coaching, and guidance &amp; lead the team towards a high-performing team.</li><li>Leads the team as the expert point of contact for facilities and utilities for the whole plant and provides support accordingly.</li><li>Owns Technician Training and development systems in support of Technician Progression</li><li>Responsible for Site Daily Meeting Cadence with Tier 1-4 meetings and ensure they are healthy for results sustainability.</li><li>To guard standards and regulations on EHS, QFS, and other fundamentals by participating in and coaching during Leader Led Observations, Safety 7, Golden 6, and other EHS and QFS activities.&nbsp;</li><li>Always maintain a good level of documentation and evidence management to support all internal and external audits. (QFS, KWS, EHS, DOSH, FSSC, HACCP, HALAL, and Global programs on FUS)</li></ul> Requirements: <ul><li>Degree in Chemical/Mechanical/Electrical Engineering or related discipline with at least 10 years of working experience.</li><li>Sound practical knowledge of mechanical engineering (rotating equipment, fasteners, bearings, gearbox, valves, thermodynamics, material strength &amp; compatibility, etc.)</li><li>Sound technical knowledge of utilities &amp; facilities equipment working mechanism and working principle (compressed air, WWTP, HVAC, chiller, coiler, hoist, rapid door, building maintenance (roof, drain, floor, etc.), electrical power supply, water supply, gas supply, nitrogen gas supply, etc.)</li><li>Preferably having work experience in F&amp;B industries with experience in SAP system</li><li>Technical experience in the following systems:&nbsp;</li><li>Six Sigma DMAIC process and strong analytical knowledge to lead and resolve complex issues.</li><li>Strong knowledge and awareness of different types of leadership and hands-on experience.&nbsp;</li><li>Capable of formulating different types of strategies to increase reliability, effectiveness, and collaboration of facilities and utilities teams to drive results in a sustainable way</li><li>Numerical literacy of basic electrical engineering (motor power, electrical load, cable sizing) and process engineering (basic mathematics related to the physics of pressure, temperature, level, force, etc.)</li><li>Sound hands-on experience in facilities &amp; utilities maintenance strategy formulation and conducting insourcing maintenance.&nbsp;</li><li>Exposed and have hands-on experience with pillar approached performance management (KWS), CI tools, analysis tools, sound problem-solving skills, and coaching skills.</li><li>Six Sigma Green Belt project implementation experience &amp; CAPEX project management will be an added advantage</li></ul>

Responsibilities: Investigation Management <ul><li>Timely review and support to closing of OOS/OOT/Deviations/Market complaints/Customer notifications as an investigational SME Role.</li><li>Review and ensure identified Root cause/Hypothesis is based on sound scientific Rationale and evidence.</li><li>Review and ensure Investigation order is proper and logical.</li><li>Review and ensure Investigation articulation is proper and not Misleading /Ambiguous.</li><li>Review and ensure Identification of CAPA’s is consistent with investigation findings</li><li>Provide appropriate rating to Root cause investigation based on Hypothesis, Investigation order, Investigation articulation and Identification of CAPA’s.</li><li>Undertake continuous trainings and developments from an outcome of Investigations and CAPA’s.</li><li>Implementation of best practices in Investigation review mechanism, policies, processes and procedures to aid and improve operational performance and Quality Metrics.</li><li>Support to Implement all relevant procedures described in the Quality Management System (QMS) like Deviation, RCI, Complaint management etc.,</li><li>Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance.</li><li>Work collaboratively, negotiate and engage with key stakeholders to facilitate delivery and compliance with the quality strategy.</li><li>Review and identify areas of improvement in the investigations.</li><li>Ensure the compliance with current industrial practices and constantly meet the regulatory requirement with zero integrity issue.</li></ul> Workload Management&nbsp; <ul><li>Coordinate workload sharing with Investigators team and develop action plans to improve timeline and quality of investigations</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li></ul> Staff Development	 <ul><li>Evaluate potential candidates for Investigation team, performance evaluation of direct reports.</li></ul> Requirements: Education &amp; Experience&nbsp; <ul><li>Bachelor’s degree in pharmacy, Chemistry, Biotechnology, or related scientific discipline (master’s preferred)</li><li>10+ years of experience in pharmaceutical manufacturing, quality, or compliance roles, including investigation management</li><li>Prior experience leading teams and conducting root cause analysis for deviations, OOS/OOT, and quality events</li><li>Working knowledge of FDA, EU, and other global regulatory requirements Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>In-depth understanding of cGMP regulations, 21 CFR Part 211, ICH Q9/Q10 principles</li><li>Strong knowledge of manufacturing and QC processes for solid oral dosage forms, non-sterile liquids and semi-solid dosage forms</li><li>Familiarity with investigation tools and techniques (e.g., 5 Whys, Fishbone, FMEA)</li><li>Experience with Quality Management Systems (e.g., TrackWise, MasterControl)</li><li>Skills &amp; Abilities Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support - Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People - Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li><li>Excellent analytical thinking and problem-solving skills</li><li>Excellent critical thinking and root cause analysis skills</li><li>Ability to work cross-functionally and influence without authority</li><li>Proven ability to meet deadlines while handling multiple investigations</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Ability to work on-site full-time in both office and GMP environments</li><li>Sit or stand for extended periods; walk between manufacturing and laboratory areas</li><li>Ability to occasionally lift or move materials up to 25 pounds</li><li>Use of personal protective equipment (PPE) as required Investigation Management</li></ul>

Skills

Industry

Location

Jobtitle

35 laboratory equipment Jobs found

Line Manager (Improvement)

Supervisor III Materials Planning

Sales Manager – Device Business (South Zone)

Sales Manager – Device Business (East Zone)

Technical Support Specialist

PVD Equipment Engineer

Manager, Analytical Quality Assurance

Exports Manager APAC

Facilities & Utilities Manager

Site Investigation Lead, Quality Assurance

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Skills

Industry

Location

Jobtitle

35 laboratory equipment Jobs found

Line Manager (Improvement)

Supervisor III Materials Planning

Sales Manager – Device Business (South Zone)

Sales Manager – Device Business (East Zone)

Technical Support Specialist

PVD Equipment Engineer

Manager, Analytical Quality Assurance

Exports Manager APAC

Facilities & Utilities Manager

Site Investigation Lead, Quality Assurance

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

EMPLOYER

TALENT

COMPANY

Contact Us

JOBS BY SKILLS

JOBS BY FUNCTION

JOBS BY INDUSTRY

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.