Packaging Technologist

Manager, Analytical Quality Assurance

Robotic Process Automation (RPA) Lead/ Specialist

Senior Devops Engineer

Preventive Maintenance Manager

Business Unit Head Medical Device

Cybersecurity Incident Response & Technology Specialist

Team Member (Vice President)

Business Support Supervisor II

Site Investigation Lead, Quality Assurance

Responsibilities: <ul><li>Responsible for identification of value transformation/cost efficiency projects &amp; ensure successful implantation of the initiatives through due qualifications and cross functional collaboration.&nbsp;</li><li>Create technical drawings, Review and approve artwork changes for Enstek site for all Pringles SKU&nbsp;like canister, flexibles, cartons, cases &amp; all types of consumer promotions.</li><li>End to end&nbsp;packaging support for new plant vertical start up.&nbsp;</li><li>Supply chain support for Plant operational issues/Trouble shooting/PM quality rejections.&nbsp;</li><li>Review &amp; validation of all type of packaging master data’s, BOM in the system.</li><li>Review historical data, performance and quality issues in all packaging lines to assess the improvement opportunities. Provide recommendations/ implementation plan to improve Enstek pringles&nbsp;and other Snacks sites for improved $/kg packaging improvement. Ensuring company systems including SCR process are followed.</li><li>Support alternate vendor development pipe line for future generation packaging.</li><li>Development of material testing protocols&nbsp;&amp; validation for new SKU/ new food development process &amp; SOP.</li><li>Develop Loadbility matrix &amp; update SC team time to time.</li><li>Contribute &amp; drive the development &amp; implementation of packaging optimization/ improvements for Pringles&nbsp;and other Snacks category.&nbsp;</li><li>Supports environmental sustainability agenda for Enstek&nbsp;&amp; Thailand plant with focus on the&nbsp;industry and company commitments.&nbsp;</li><li>Accountable for successful handover of responsibility for launched/ renovated products to Supply Chain by completing documentation and training relevant personnel in new products and processes</li><li>Prepares and maintains material specifications ensuring materials comply with all relevant Governmental requirements for food packaging.</li></ul> Requirements: <ul><li>Bachelor’s degree in food, packaging, material science or related field with min 6-8 years of experience in a packaging development related environment within FMCG food /Snacks industry&nbsp;</li><li>Strong negotiation and influencing skills.</li><li>Fluency in English – Oral and Written communication is Must</li><li>Detailed understanding of the packaging material performance and product requirements.&nbsp;</li><li>Strong team interaction skills to allow maximum influence on the business operation</li><li>Strong technical, analytical, communication and project management skills&nbsp;</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>Lead and manage a team of RPA developers and analysts to deliver end-to-end automation projects.</li><li>Analyze business processes and identify opportunities for automation using RPA tools like UiPath, Power Automate.</li><li>Design, develop, test, deploy, and maintain RPA solutions according to best practices.</li><li>Work closely with stakeholders to understand their needs and ensure successful project delivery.</li><li>Contribute to the governance and best practices of RPA engagements within the Center of Excellence (CoE).</li><li>Liaise with cross-functional teams, such as cyber security, Active Directory (AD), AWS etc to address any roadblocks and ensure smooth project execution.</li><li>Monitor and troubleshoot RPA bots in production, identifying and resolving errors to ensure smooth operation.</li><li>Train and mentor business users on RPA capabilities.</li><li>Manage client relationships and demonstrate the value of automation through workshops and demos.</li><li>Create and maintain project documentation, including process design documents (PDDs), solution design documents (SDDs), and technical design documents (TDDs).</li><li>Continuously improve RPA processes for increased efficiency and scalability.</li></ul> Requirements: Desired Skills: <ul><li>Graduate/Masters in software engineering/IT/Computer Science or equivalent.</li><li>Minimum 5 to 8 years of relevant RPA experience with tools like UiPath, Power Automate.</li><li>Familiarity with incident, problem, change management processes.</li><li>Expert vendor management skills.</li><li>Top notch communication skills as the close interactions with multiple business stakeholders are needed.</li><li>Have an eye for automation opportunities.</li><li>Very good technical writing skills.</li><li>Passionate about mentoring team.</li></ul>

Responsibilities: You will make an impact in the following way: Advanced Troubleshooting:&nbsp; <ul><li>Diagnose and resolve complex issues related to the cloud application, involving in-depth of the application architecture and infrastructure.</li></ul> Root Cause Analysis:&nbsp; <ul><li>Conduct thorough root cause analyses for recurring issues, implement preventive measures, and provide insights for continuous improvement.</li></ul> Automation and Scripting:&nbsp; <ul><li>Develop and utilize scripts and automation tools to streamline processes, improve efficiency, and reduce manual intervention in issue resolution.</li></ul> Documentation:&nbsp; <ul><li>Maintain comprehensive documentation for troubleshooting procedures, system configurations, and resolutions to facilitate sharing and future reference.</li></ul> Customer Communication:&nbsp; <ul><li>Effectively communicate with customers, providing clear and timely updates on issue resolution progress and collaborating on preventive measures.</li><li>You will be responsible for High Performance, Scalable, Robust, and Secure Common SaaS Framework based on AWS/OCP infrastructure.&nbsp;</li><li>This framework allows customers to configure provision, upgrade &amp; monitor various network functions in carrier grade enterprise &amp; telecom networks.&nbsp;</li></ul> Security and Compliance:&nbsp; <ul><li>Ensure the security of systems and applications, adhere to compliance requirements, and implement best practices for data protection.</li></ul> Collaboration:&nbsp; <ul><li>Collaboration with internal and external stakeholders.&nbsp;</li><li>Work closely with development, QA, and operations teams to foster a culture of collaboration and continuous improvement.&nbsp;</li><li>Collaborate with client’s team to gather the requirements.</li></ul> Training and Mentorship:&nbsp; <ul><li>Provide guidance and mentorship to junior team members and promote sharing within the organization.</li><li>Troubleshoot and fix any customer issues identified internally or in the production deployments.</li></ul> Requirements: <ul><li>5-8 years of Experience in DevOps (Jenkins, AWS services, Kafka, Grafana, elastic search, Bitbucket, Git, Deployment, Documentation, Root Cause Analysis reports, Customer interactions etc)</li><li>Experience with Cloud-native SaaS development &amp; virtualization technologies, for example, AWS, ESXi, KVM, HyperV would be a plus.&nbsp;</li><li>Extensive experience in developing distributed system design.</li><li>Prefer experience with microservice architecture, large scale, public cloud, IAM</li><li>Strong knowledge of containerization technologies like Kubernetes and Docker.&nbsp;</li><li>Strong knowledge in public cloud technologies (preferably AWS) and on-premises setups.</li><li>Good knowledge of analysing backend, frontend code whenever required and able to perform some tests as per customer issues.</li><li>Experience with CI/CD tooling like Jenkins etc.</li><li>Experience with version control system like Git, Bitbucket.</li><li>Experience with IaaC (Infrastructure as a Code) tools like Terraform.</li><li>Familiarity with agile development methodologies.&nbsp;</li><li>Lead and participate in various scrum ceremonies.</li><li>Good knowledge of observability tools like Kibana, Elastic stack, Prometheus stack etc.</li><li>Good knowledge of Linux operating system</li><li>Good knowledge of programming languages like Shell scripting, Python etc.</li><li>Knowledge of REST API, API gateways&nbsp;</li><li>Effective communication skills – written, spoken, listening and presentation.&nbsp;</li><li>Great Team player and experience working with global teams and global organizations.&nbsp;</li><li>Bachelor’s in computer science or equivalent.&nbsp;</li><li>Preferably a master’s degree in computer science.</li></ul>

Responsibilities: <ul><li>Lead the team of 3 Storekeepers, 1 PM executive, and 2 PM technicians for end-to-end preventive maintenance and technical store operation.&nbsp;</li><li>Conducts all the preparation, planning, execution, and closure of the preventive maintenance tasks in SAP and keeps a good track record and compliance.</li><li>Accountable for purchasing, inventory management, stock count, inventory compliance, and conducting stock item analysis (most usage, highest value, slow-moving, obsolete, etc)</li><li>Accountable for all the KPIs for world-class PM &amp; MRO management as outlined in RM COE Phase 1 -3.&nbsp;</li><li>Drive engineering department weekly meetings by organizing, preparing templates for data inputs, KPI review, conducting data analysis, and delivering plant USDT and reliability.&nbsp;</li><li>Constantly conducts data analysis on preventive maintenance plans and spare parts usage to deliver preventive maintenance optimization for cost-effective maintenance.</li><li>Lead root cause analysis and problem-solving capability increase in engineering.</li><li>Lead KWS RM COE and own MROS element as part of the technical store operation.</li><li>Drive implementation of KWS for RM COE among engineering, technical, and operations teams with regular engagement, preparation, and training.</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 R&amp;M cost budgeting and end-to-end management and monitoring. 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>Responsible for Site Daily Meeting Cadence with Tier 1-4 meetings and ensure they are healthy for results sustainability.</li><li>Lead people management for all direct reports and his/her -1 &amp; -2. Manage their performance, KPI delivery/formulation, and capability building effectively.</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>Lead, and involvement in 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 &gt; 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>Practical knowledge of process equipment working mechanism and working principle (fryer, mixing, grinding, canister filling, packing machines, conveyors, etc.)</li><li>Sound work experience in F&amp;B industries with experience in SAP technical store management in support of entire plant operation.</li><li>Sound experience in managing preventive maintenance end-to-end processes to drive the highest level of compliance and machine reliability.&nbsp;</li><li>Technical and hands-on experience in the following systems:&nbsp;</li><li>Profound experience in food manufacturing process flow and in-depth experience in machine mechanisms and concepts. (dry mixing, dumping, wet mixing, conveying system, frying, seasoning, filling and packing)</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>Preferably with some process literacy in building maintenance, HVAC, compressed air supply, utility gas supply, potable and wastewater treatment</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>Good leadership skills and capable of managing 24/7 plans with critical thinking and strong people management skill.&nbsp;</li><li>Six Sigma Green Belt will be added advantage.</li></ul>

Responsibilities: Strategic Leadership: <ul><li>Collaborate with the CEO to set and drive the organizational vision and operational strategy.</li><li>Translate strategy into actionable steps for growth, implementing organization-wide goal setting, performance management, and annual operations planning.</li><li>Oversee the company’s overall operations, including finance, IT, legal, and HR, ensuring a highly inclusive culture.</li><li>Hire team with right capabilities, develop and mentor them to achieve objectives</li></ul> Operational Management: <ul><li>Oversee operations, HR, and accounting.</li><li>Partner with the CEO in sales management to ensure sufficient investment capital for growth targets.</li><li>Build and maintain trusting relationships with key stakeholders, clients, and partners.</li><li>Planning and achieving month on month business and sales goals.</li></ul> Financial Oversight: <ul><li>Oversee financial data and recommend solutions to improve profitability.</li><li>Maintain and manage the Profit &amp; Loss (P&amp;L) sheet for the business unit.</li><li>Closely monitor budgeting, forecasting, and expense management.</li><li>Preparing pricing offers, public and private procurements tenders and projects</li></ul> Market and Business Development: <ul><li>Develop and execute a comprehensive business strategy for the medical devices business to achieve revenue, market share, and profitability targets.</li><li>Enhance brand positioning, engage key opinion leaders, and promote products effectively.</li><li>Conduct thorough risk assessments to identify and mitigate potential challenges in the competitive environment.</li></ul> Requirements: <ul><li>Proven ability to multitask, prioritize, and manage time effectively.</li><li>A good understanding and familiarization of the clinical Medical Device environment, competitor products – Preferably in ultrasound business</li><li>Strong interpersonal and analytical skills.</li><li>Excellent leadership, communication, and negotiation skills.</li><li>Deep understanding of the healthcare industry, partner relationship management, and identifying new revenue opportunities.</li><li>Strategic planning and execution capabilities.</li><li>Experience in market development and awareness.</li><li>Expertise in revenue generation and P&amp;L management.</li><li>Competence in Key Account Management (KAM) and operations management.</li></ul>&nbsp;Experience: <ul><li>Experience: 10-15 years in the medical devices industry.</li><li>Demonstrated success in sales and marketing of medical devices.</li><li>Strong background in P&amp;L management.</li><li>Ability to stabilize current business operations and deliver on set objectives.</li></ul>&nbsp;

Responsibilities: <ul><li>Incident Management: Efficiently assess, investigate, and manage security incidents throughout their lifecycle, determining root cause and impact.</li><li>Log Analysis: Conduct comprehensive analysis of security logs and data to identify and correlate malicious activity.</li><li>Incident Response Leadership: Lead incident response efforts, contribute to the development and maintenance of incident response plans, and coordinate effectively with relevant stakeholders.</li><li>Technology Evaluation: Conduct thorough Proof of Concept (PoC) and Proof of Value (PoV) assessments of prospective security tools to determine their efficacy and suitability.</li><li>Project Management: Apply project management principles to plan, execute, and monitor the implementation of security tools and strategic initiatives.</li><li>Technical Communication: Articulate complex technical information clearly and concisely to both technical and non-technical audiences.</li><li>Cross-functional Collaboration: Collaborate effectively with diverse teams to facilitate incident resolution and the implementation of security solutions.</li><li>Continuous Improvement: Conduct post-incident reviews to identify lessons learned and recommend enhancements to prevent future occurrences.</li><li>Security Tool Proficiency: Utilize tools such as EDR and SIEM for in-depth investigations and analysis.</li><li>Availability: Respond to security incidents on a 24x7 basis during escalations and participate in a rotational on-call schedule, including weekends and public holidays.</li><li>Additional Responsibilities: Undertake other cybersecurity-related tasks as directed by team leadership.</li></ul> Requirements: <ul><li>Bachelors degree in Computer Science, Information Security, or a related discipline, or equivalent professional experience.</li><li>A minimum of eight (8) years of demonstrable experience in cybersecurity incident response.</li><li>Comprehensive understanding of network protocols, operating systems, and fundamental security principles.</li><li>Proven ability to analyze security logs and network traffic effectively.</li><li>Exceptional problem-solving, analytical, and communication skills (both written and verbal).</li><li>Experience in conducting Proof of Concept (PoC) or Proof of Value (PoV) evaluations of security technologies.</li><li>Demonstrated knowledge and application of project management principles.</li><li>Familiarity with security tools and technologies, including CrowdStrike EDR and Splunk.</li><li>Relevant professional certifications, such as CISSP, GCIH, or CEH, are highly desirable.</li></ul>

Responsibilities: <ul><li>Preparation of documentation and conduct CDD in a timely manner</li><li>To liaise with RMs on the required documentation</li><li>Ensure that ongoing CDD reviews are conducted in tandem with internal process and policies</li><li>Ensure data accuracy in systems and documentation</li><li>Extraction of data from worksheets and reports for distribution to respective Business segments for necessary follow-up actions</li><li>Assisting BUs to respond to various CDD enquiries, which may originate from the local authorities or from correspondent banks, over client’s profile</li><li>Perform screening assessment and escalate material hits, where applicable for further clearance.</li><li>Assisting the Team Leader in providing regular statistics and presentations for updating to Senior Management</li><li>Participating in ad-hoc assignments and projects, e.g., audit, user acceptance testing etc. where required</li><li>Providing advisory support to the BUs in CDD related matters, where applicable</li></ul> Requirements: <ul><li>Tertiary holder and above</li><li>Prior working experience of at least 4-6 years in KYC / CDD roles.</li><li>Detail-oriented, yet able to think flexibly and independently to resolve problems</li><li>Knowledge of MAS regulations will be an added advantage.</li><li>Maintaining a high degree of knowledge in MAS 626 regulations and associated regulatory requirements for AML/CFT and Sanctions.&nbsp;</li><li>Emotionally mature and able to communicate maturely and independently with various stakeholders within the Bank</li><li>Comfortable with data handling, and able to perform functions on Excel, such as VLOOKUP, Pivoting and generating various graphs / charts, etc.</li><li>Attentive to details with a strong sense of interest in developing a career as a KYC / CDD specialist</li><li>Good command of both written and spoken English. The ability to speak / read additional languages is an advantage</li><li>Able to raise sensitive or potentially contentious issues in a constructive manner to arrive at appropriate solutions</li><li>Self-driven and a team player with strong interpersonal skills to communicate, influence and negotiate</li><li>Certification as an AFC specialist (e.g., CAMS / Diploma in AML, Governance and Risk) with a recognized institution will be an advantage</li><li>Proficient in Mandarin is an added advantage</li></ul>

Responsibilities: Administrative Support: <ul><li>Provide administrative support to the Plant Manager, including calendar management, scheduling meetings, and arranging travel.</li><li>Prepare and manage correspondence, reports, presentations, and other documents as needed.</li><li>Manage the plant manager’s communications and act as a point of contact for both internal and external stakeholders.</li></ul> Document Management: <ul><li>Maintain and organize important plant records&nbsp;</li><li>Assist in the preparation and tracking of reports related to plant performance, operational costs, and production targets.</li><li>Ensure compliance with plant regulations and documentation standards.</li></ul> Coordination and Communication: <ul><li>Act as a liaison between departments ensures effective communication and smooth operations.</li><li>Coordinate plant-wide meetings, production schedules, and internal communications between staff and management.</li><li>Assist in the preparation and execution of plant meetings, taking minutes and ensuring follow-up on key action items.</li></ul> Data Analysis and Reporting: <ul><li>Assist in gathering, compiling, and analyzing plant performance data to help the Plant Manager&nbsp;</li><li>Prepare reports for the Plant Manager to track key performance indicators (KPIs), production performance, and safety metrics.</li></ul> Process Improvement: <ul><li>Assist with operational efficiency initiatives, providing administrative support to process improvement teams.</li><li>Help manage and track plant projects, ensuring they are completed on time and within budget.</li><li>Provide insights and suggestions to improve plant operations and reduce costs.</li></ul> Requirements: <ul><li>Bachelor’s degree in business administration, Management, or a related field.</li><li>Proven experience in administrative or business support roles, preferably in a manufacturing or industrial environment.</li><li>Strong organizational skills and the ability to prioritize multiple tasks.</li><li>Excellent communication skills (written and verbal).</li><li>Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).</li><li>Experience with data analysis and report generation is a plus.</li><li>Ability to work independently and as part of a team.</li></ul> Additional Skills: <ul><li>Knowledge of plant operations and manufacturing processes is advantageous.</li><li>Strong attention to detail and problem-solving skills.</li><li>Ability to handle confidential information with integrity.</li><li>Strong time-management skills and ability to meet deadlines</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>

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108 tm master data Jobs found

Packaging Technologist

Manager, Analytical Quality Assurance

Robotic Process Automation (RPA) Lead/ Specialist

Senior Devops Engineer

Preventive Maintenance Manager

Business Unit Head Medical Device

Cybersecurity Incident Response & Technology Specialist

Team Member (Vice President)

Business Support Supervisor II

Site Investigation Lead, Quality Assurance

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108 tm master data Jobs found

Packaging Technologist

Manager, Analytical Quality Assurance

Robotic Process Automation (RPA) Lead/ Specialist

Senior Devops Engineer

Preventive Maintenance Manager

Business Unit Head Medical Device

Cybersecurity Incident Response & Technology Specialist

Team Member (Vice President)

Business Support Supervisor II

Site Investigation Lead, Quality Assurance

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

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