Finance Manager

MFG & Process Development Engineer II – Molding

Quality Engineering Supervisor

Channel Account Executive

Finance Analyst – Plant Operations (FP&A)

Line Manager (Improvement)

Supervisor III Materials Planning

Manager, Analytical Quality Assurance

Senior Devops Engineer

Site Investigation Lead, Quality Assurance

Role Description: <ul><li>Support the FF SSA Head of Finance and operational companies with the full end to end financial reporting and FP&amp;A functions as well as related strategic initiatives.</li></ul> Responsibilities: <ul><li>Provide support and actively engage with the operational teams on various finance matters.</li><li>Daily review profitability reports, with escalations with operations for corrections</li><li>Reconciliations between ERP systems (CargoesRunner, Oracle Fusion, Local ERP)</li><li>Manage month end and financial control processes.</li><li>Manage the month end close process and prepare the related reporting to the FF Regional HO</li><li>Detailed reviews of actuals against budget and forecast.</li><li>Detailed reviews of gross profit and exception reporting and management with Operating company(ies)</li><li>Involved in the preparation of budgets and forecasts for the operating company(ies)</li><li>Review and/ or prepare weekly cash flow forecasts.</li><li>Net working capital management&nbsp;</li><li>Manage the accounts receivable and accounts payable processing and month-end close process.</li><li>Consolidation of financial and management reporting, ensuring accuracy of financial information, as well as timeous preparation of monthly, quarterly and annual reporting within deadlines.</li><li>Preparation of Hyperion packs.</li><li>Detailed application of IFRS requirements in consolidation and mergers and acquisitions.</li><li>Perform reviews of monthly reconciliations for the Operating company (ies)</li><li>Support the annual and interim external financial audit.</li><li>Work closely with the regional finance teams ensuring alignment of Group processes and procedures.</li><li>Support and play a key role in M&amp;A activities.</li><li>Support and play a key role in new finance system implementations and finance process improvements and IFRS technical matters.</li><li>Ensure operating companies are compliant with tax legislation.</li><li>Ensure compliance with IFRS, Tax etc.</li><li>Prepare accurate and timely statutory financial statements annually.</li><li>Custodian or Risk, Internal Controls and Governance for the country&nbsp;</li><li>Responsible for the management and leadership of an engaged team, promoting collaboration and ensuring that each is developed and evaluated against goals and objectives which are aligned, specific, measurable, attainable yet challenging, realistic and time bound.</li><li>Act as an ambassador at all times when working; promoting and demonstrating positive behaviours in harmony with Principles, values and culture; ensuring the highest level of safety is applied in all activities; understanding and following Code of Conduct and Ethics policies.</li><li>Perform other related duties as assigned.</li></ul> Requirements: Qualification <ul><li>Minimum Honours degree in relevant field</li><li>CA (SA)/ CIMA/ or equivalent</li></ul> Experience <ul><li>At least +5 years of experience directly related to the duties and responsibilities specified.</li><li>Experience in the Clearing and Forwarding environment.</li></ul> Skills Behavioural Competencies: <ul><li>Proven leadership and influence.</li><li>Ability to work under pressure with excellent attention to detail and time management skills.</li><li>Proven ability to multitask and ensure effective delivery of the priorities to meet targets and objectives.</li><li>Excellent communication skills.</li><li>Decision making and problem-solving skills.</li><li>Ability to work and keep up in a fast-paced, changing business environment.</li><li>Ability to prioritize and meet tight deadlines.</li><li>Adapting &amp; responding to change.</li><li>Proficient stakeholder management.</li><li>Analytical: You are able to think critically, analyze data, assess risks and opportunities within complex business situations and solve problems.</li><li>Coping with pressure.</li></ul> Technical Competencies: <ul><li>Analytical and financial modelling.</li><li>Proficient in Excel and PowerPoint.</li><li>Proficient Hyperion knowledge.</li><li>Proficient Oracle knowledge.</li><li>Proficient with IFRS and corporate tax in Africa.</li></ul>

Responsibilities: <ul><li>Overall molding process development, coordinating with interaction processes (Stamping, Plating, Assembly) to ensure the best process and cost for F/Gs</li><li>Concept design &amp; proofing for Molding process and tooling, Process development DOE.</li><li>Technical leader and trouble shooter from LVM to HVM in process development, tooling design &amp; qualification, issue finding and problem solving</li><li>Platforming manufacturing process development.</li><li>Challenge product design for manufacturability and cost feasibility.</li><li>Launch product at rate through FACA/QCPA tools (yield, CPK, OEE…)</li><li>Launch product on time with cross function team.</li><li>Process documentation (DFM，FMEAs, WI, FACA/QCPC…)</li></ul> Requirements:﻿ <ul><li>Bachelor or above degree in mechanical engineering or related background.</li><li>5+ years Mold design, Process and Troubleshooting knowledge / experience.</li><li>Strong knowledge of tool fabrication, tool-steel application/selection, heat treating, and plating/coating.&nbsp;</li><li>Strong knowledge of injection molding processes (Injection, Insert-molding, two-shot, etc.).</li><li>Strong understanding of plastic, injection machine, auxiliary equipment (strip feed, camera, etc).</li><li>Good at Mold flow simulation and analysis.</li><li>Familiar with BTI 5-Step process, and Knowledge of SIM (Scientific Injection Molding).</li><li>Understand tolerance calculations and Geometric Dimensioning and Tolerancing.</li><li>Data oriented issue finding and problem-solving skills.</li><li>Rich shopfloor hand on experience.</li><li>Sensitive on product cost, know how to drive cost through manufacturing process development &amp; design optimization.</li><li>Fluent in using of basic process development related tools like DFM, PFMEA，DOE，FAA, CTAR，CAD，Pro E</li><li>Knowledge of quality control and quality issue analysis and improvement</li><li>Good teamwork and communication skills。</li><li>Fluent in written and Spoken English.</li><li>Oversea working experience is a plus</li></ul>

Responsibilities: <ul><li>Lead a team of customer-facing quality engineers to provide root cause analysis and corrective action communications to our customers during quality issues within our target timeframes.</li><li>Utilize formal problem-solving techniques to resolve product and process-related issues, leading cross-functional teams.</li><li>Lead cross-functional Notice of Escape teams to ensure containment, root cause analysis, corrective action, and communication to customers.</li><li>Evaluate customer requirements during order processing, drive implementation of new customer-specific requirements, and negotiate requirements not in the best interest of the company.</li><li>Design and develop forms and instructions for recording, evaluating, and reporting quality data.</li><li>Review and approve First Article reports.</li><li>Work cross-functionally to disposition nonconforming product found at incoming, in process, or returned from customers and approve any deviations required.</li><li>Support direct reports through coaching, development, and prioritization of responsibilities. Hold direct reports accountable for results and task completion.</li></ul> Requirements: <ul><li>Bachelor’s Degree required in a related field such as Engineering, Quality, or Reliability Engineering.</li><li>7+ years of industry experience, including 2+ years supervising others.</li><li>Up to 10% travel may be required, including international travel.</li><li>Excellent presentation skills, along with strong written and verbal communication skills.</li><li>Must possess strong problem-solving skills. Advanced problem-solving tools such as Lean Six Sigma Green Belt or Shainin Red X Journeyman are a plus.</li><li>Excellent negotiation skills both internally and externally to drive completion of 8D documents that advance the organization toward world-class manufacturing.</li><li>Experience leading problem-solving teams and using tools such as 8D, 5-Why Analysis, and Fishbone Diagrams.</li><li>Working knowledge of quality systems in an ISO9001/AS9100 environment is a plus.</li><li>Strong computer skills, including proficiency in SAP, Microsoft Word, Excel, and PowerPoint.</li></ul>

Responsibilities: <ul><li>Reconcile payments from Partner &amp; Direct customer accounts, and to streamline financial processes and systems, and report inconsistencies to the manager, identifying potential collectors and report partners with inconsistent payment track, streamlining the collectables.&nbsp;</li><li>Strengthen and grow relationships with partners or direct customers by timely communicating regarding due accounts. Timely statement and weekly follow-ups in order to avoid delays.</li><li>Determine areas for performance improvement to help streamline the accounts receivable process.</li><li>Adhere to local and national financial regulations and report financial information with honesty and confidentiality</li><li>Maintain accounts receivable records to ensure aging is up to date, credits and collections are applied, uncollectible amounts are accounted for, and miscellaneous differences are cleared.</li><li>Gather and verify invoices for appropriate documentation before payment.</li><li>Perform daily cash management duties, including the recording of bank deposits, updating and distribution of cash receipt logs, and posting of cash to the accounts receivable sub-ledger.</li><li>Monitor and collect accounts receivable by contacting clients through Physical visits, telephone, and email.</li><li>Prepare analytical and ratio analyses relevant to A/R so management can gain a better understanding of how collection efforts are progressing.</li><li>Support other accounting and finance team members, inventory management, and cost accounting.</li></ul> Requirements:﻿ <ul><li>Education – Bachelor’s degree with a minimum of 10 years’ experience related to accounts receivable/payable</li><li>Markets – Strong knowledge of MS Office (Excel, Word, PowerPoint). Core Competencies - Credit Management &amp; Control, Debt Collection &amp; Management, Report generation, and MIS Reporting. Experience in handling large partners or key accounts.&nbsp;</li><li>Customers Define our Success – Deep understanding on principles of finance, accounting, and bookkeeping. Effective time management skills are needed to handle the diverse and challenging position</li></ul>

Responsibilities: Planning and Budgeting: <ul><li>Assist on annual budget preparation.</li><li>Assist on monthly forecast preparation.</li><li>Track weekly forecast variance. In order to provide accurate and timely reports.</li></ul> Inventory Risk tracking/Analysis: <ul><li>Inventory reserve preparation</li><li>High light inventory risks and opportunities monthly</li><li>Monitor inventory physical count.</li><li>In order to comply with corporate policies and risk control</li></ul> Costing accounting: <ul><li>Data prepare(Mater master/Routine/Std cost);</li><li>Mth ending JE booking</li><li>PPV programme and analysis</li><li>Mat. usage analyzing&nbsp;</li><li>Production scrap report preparing</li></ul> FA accounting: <ul><li>Familiar with Capital Assets policy and comply with the policy(Include local policy)；</li><li>Prepare FA management report(Acquisitions, disposal, transfer etc.) and leading fixed&nbsp;</li><li>assets physical count</li><li>Issuing Asset Tags to assets responsible department</li><li>Intercompany Transfers of Fixed Assets data preparing and follow to financial posting</li><li>Follow Open PO&amp;IO&amp;CIP tracking report by month</li><li>CER review and budget control with report and management.</li></ul> Requirements: <ul><li>At least bachelor’s degree in finance/accounting/taxation or related.</li><li>Over 3 years working experience in Finance, costing managerial position is preferred&nbsp;</li><li>Good knowledge and experience in costing of manufacturing. Understand how to manage and improve Mfg. variance.&nbsp;</li><li>Good knowledge and experience in SAP.</li><li>Fluent English Mandarin, both written and oral</li><li>Strong will to learn and develop the skills.</li><li>Excellent Attention to Details</li></ul>

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: 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: 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: 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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45 control precision Jobs found

Finance Manager

MFG & Process Development Engineer II – Molding

Quality Engineering Supervisor

Channel Account Executive

Finance Analyst – Plant Operations (FP&A)

Line Manager (Improvement)

Supervisor III Materials Planning

Manager, Analytical Quality Assurance

Senior Devops Engineer

Site Investigation Lead, Quality Assurance

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45 control precision Jobs found

Finance Manager

MFG & Process Development Engineer II – Molding

Quality Engineering Supervisor

Channel Account Executive

Finance Analyst – Plant Operations (FP&A)

Line Manager (Improvement)

Supervisor III Materials Planning

Manager, Analytical Quality Assurance

Senior Devops Engineer

Site Investigation Lead, Quality Assurance

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