Job Description

Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our scien Why Patients Need You Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients. Position Summary The incumbent is member of the Quality Control (QC) Laboratory team. Under the supervision of the Senior QC Manager, the incumbent will be responsible for the Quality Control operational aspects of all analytical testing and/or AMTE (Analytical Method Transfer Exercise) activities within the QC Laboratory. Key accountabilities include: . Lead, coach and develop the QC personnel (analysts, chemists and/or microbiologists) to ensure that analytical testing (chemical, physical and/or microbiological) / data review and AMTE activities are performed in a safe and reliable manner to support manufacturing operations across all shifts with adherence to site Standard Operating Procedures (SOPs). . Ensure that the quality systems and practices in the laboratory comply with Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs), current Good Manufacturing Practices (cGMPs) and Pfizer Quality Standards (PQS). . Deploy and use Imex 'way of working' for day to day operations, problem solving, escalation and continuous improvements. Responsibilities and Job Related Requirements Responsibilities: . Supervise QC personnel in operational aspect of performing testing, e.g. troubleshooting laboratory equipment failure and laboratory investigation. . Supervise QC personnel to ensure Data Integrity (DI) and ALCOA principles are adhered to in all QC laboratory operations (e.g. testing and data review activities). . Review analytical and / or microbiological results (for in-process, product, intermediates and/or raw materials, cleaning samples, test method development and/or validation / verification protocols). . Review and approve documentation associated with AMTE (Analytical Method Transfer Exercise), test method development, validation or verification. . Conduct laboratory investigations and ensure all follow up actions are completed. Make decisions based on scientific and logical reasoning on behalf of the QC manager when required. . Manage testing activities (e.g. raw materials, intermediates, Active Pharmaceutical Ingredients (APIs), stability) to meet committed schedule and to optimize laboratory capacity utilization. . Responsible for the development, maintenance and communication of the laboratory testing/release capacity planning based on demand forecasts, testing / release lead times, resource availability (equipment, manpower) and budget requirements. . Write and review working procedures for QC laboratory. . 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. . Train fellow colleagues on written procedures pertaining to equipment operation, test methods and general laboratory operation. . Conduct training to increase staff knowledge and understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) requirements, product chemistry and sophisticated laboratory equipment. . Manage and ensure the provision of laboratory supplies (e.g. consumables, glassware) for continuity in testing activities. . Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed). . Participate in site teams/projects e.g. NPI, continuous improvement, safety-related initiatives. . Work closely with QA, Production, Technical Services, Engineering and EHS personnel to support them in laboratory testing requests and trouble-shooting when required. . Help to manage the budget of the laboratory expenses. . Develop the skills and capabilities of QC chemists, microbiologists and analysts. . 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. . Uphold Pfizer's code of conduct and values. . Collaborate with cross-functional teams to drive flawless execution. . Stand in for the QC Manager in his/her absence (where required). Job Related Requirements: . Effective problem solving skills. . Demonstrated leadership and customer service skills. . Excellent verbal, written communication and presentation skills. . Demonstrated ability to perform in a team and matrix management function. . Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories. . Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment. . Experience in Empower software/ SAP will be an added advantage. . Possess a can-do / pride to succeed attitude and be a positive influencer/role model. . Embrace the use of digital technology to scale and speed up every form of interaction and action. Education and Experience Bachelor or Master or Ph.D degree in Science (Chemistry preferred) or Life Science relating to Chemistry, Pharmacy, Pharmaceutical Science or Microbiology or a related science. Minimum 5 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable. Experience in managing/supervising small to medium (5-8) groups of laboratory analysts, chemists and/or microbiologists. For AMTE Supervisor, experience in method transfer activities, development and validation of analytical method is required. Fully complete Covid-19 vaccination and could provide official medical certificate