Senior Qc Chemist

The incumbent is a member of the Quality Control (QC) Laboratory team. Reporting to the QC Systems Manager / QC Supervisor, the incumbent will be responsible for systems related aspects supporting analytical testing in QC. These includes:

- Management of the system life cycle of QC laboratory equipment from purchasing, qualification, calibration & maintenance, periodic reviews, configuration and electronic data management to decommissioning.
- Set up and maintain QC processes (e.g. Stability program, Training plan for Analysts, Testing / Lab Release workflows and scheduling) and QC support of Continued Process Verification and/or Annual Product Reviews, including Stability and Batch testing data review / analysis.
- Lead QC processes / systems-related investigations and projects for improvement of QC processes.
- Mentor members within the Quality Control Laboratory team.
- Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements.

POSITION RESPONSIBILITIES

**Responsibilities**:

- Perform all activities in the system life cycle of QC lab instruments / equipment (selection, qualification, user management, calibration, preventive maintenance, periodic reviews, configuration and electronic data management, decommissioning) in accordance to approved site procedures and applicable standards.
- Ensure all data management for QC instrument / equipment analysis data comply to site SOPs, Data Integrity (DI) and ALCOA requirements per PQS and that they are archived / retained in accordance to existing procedures.
- Provide oversight / supervision of GMP services provided by approved vendors for QC systems. Review and approve vendor documentation (e.g. qualification packages, calibration / test reports)
- Provide operational support (e.g. troubleshooting) for QC lab instruments / equipment to ensure batch release and lab testing activities is maintained inline with committed schedules.
- Develop, maintain and communicate QC laboratory testing/release capacity planning based on demand forecasts, testing / release lead times, resource availability (equipment, manpower) and budget requirements.
- Collaborate in cross functional teams (involving Supply Chain, Manufacturing, NPI etc) to provide inputs and adjustment to test activities to support production / product shipment / NPI schedules with appropriate escalation through Tier processes.
- Manage the stability testing program, ensuring all studies are promptly initiated and all test records are reviewed. Perform trending of stability data to confirm adverse trends, stability OOS or questionable results.
- Manage the training requirements for QC chemists, microbiologists and analysts including developing and maintaining training materials, coordinating trainings and conducting instructor-led trainings.
- Provide QC support of Continued Process Verification and Annual Product Review processes, including Stability and Batch testing data analysis and review.
- Author procedures governing QC systems and processes (equipment, data systems, stability, sample flow etc) and related technical documentation (e.g. protocols and reports) in accordance to Pfizer Quality Standards.
- Author training documentation and perform training (e.g. Structured On-The-Job Training or SOJTs) for fellow colleagues on SOPs pertaining to QC instruments / equipment and QC processes.
- Lead and conduct investigations for deviations affecting QC laboratory systems or processes (e.g. Equipment failure, Stability-related investigation, Analyst training program-related), identify root cause(s) and implement appropriate corrective action and preventive measures.
- Subject Matter Expert for area of work scope (e.g. Equipment qualification and maintenance program, Stability program, Analyst training program) and ensure adherence to site procedures and PQS.
- Lead projects for improvement of QC laboratory systems and processes including Data Integrity initiatives.
- Uphold Pfizer's code of conduct and values.
- Collaborate with cross-functional teams to drive flawless execution.
- Play an active and impactful role in Tier processes by updating performance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
- Mentor junior members (including interns) within the QC team.

Job Related Requirements:

- Demonstrated leadership and customer service skills.
- Effective problem solving skills.
- Demonstrate ability to act decisively and independently to resolve issues.
- Strong verbal, written communication and presentation skills.
- Demonstrated ability to perform in a team and provide mentorship to team members.
- Comprehensive knowledge of analytical laboratory equipment system life cycle and data integrity requirements.
- Comprehensive knowledge of cGMPs and QC processes (Stability program management, QC Analyst training programs, Continued Process Verifica