Qc Systems Manager

Pfizer Singapore recruit permanent employees for manufacturing site expansion of PFIZER ASIA MANUFACTURING PTE LTD (PAMPL) in Singapore. **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 the QC expert/SME for (1) QC Instrument / Equipment and Systems (gLIMS, Empower) and (2) QC processes (e.g. Analyst training, Stability, APRR) who ensures that QC systems and processes are maintained in a validated and GMP complaint state at all times. Key accountabilities include: - Lead improvements to QC systems and processes that support Test and Release of products, delivering RFT and CI projects that value adds to QO operational cost. - Lead and support QC systems and processes related investigations and act as site expert to provide guidance to resolve issues. - Ensure that all QC systems related activities and processes comply with Good Manufacturing Practices (GMPs), Data Integrity (DI), site Standard Operating Procedures (SOPs) and Pfizer Quality Standards (PQS) policies. - Provide strong leadership to lead, coach and develop the QC Systems team to ensure that all activities are performed in a GMP compliant and safe manner to support manufacturing operations. - Deploy and use Imex "way of working" for day to day operations, problem solving, escalation and continuous improvements. **Responsibilities and Job Related Requirements**: **Responsibilities**: - Ensure Lab Systems, Instruments / Equipment are qualified and maintained in a validated and GMP compliant state at all time and in line with site safety requirements. - Ensure routine preventive maintenance of laboratory equipment are completed as per schedule and maintain a high level of QC equipment availability to support QC operational testing, supporting maximum uptime of all systems. - Responsible for correct setup and assignment of security profiles to QO systems, including appropriate training requirements. - Provide operational support to QC IT systems to ensure adherence to planned schedule for testing / release activities in QC Laboratory. - Timely completion of template built and specification updates to support changes and New Product Introduction (NPI). - Planning and execution of Stability studies and QC support of Continued Process Verification and/or Annual Product Reviews, including Stability and Batch testing data review / analysis. - Training strategy and execution for QC personnel. - Oversight of all non-conformance within the QC system team to ensure that investigations carried out are in-depth, consistent in quality and comply with Pfizer PQS and that CAPAs implemented are systematic and effective to address root cause identified. - Support regulatory inspection for all QC system related issues. - Monthly trending of system related activities and presentation to SQRT for any adverse trends. - Ensure tier processes are well managed and quality, operational safety issues, standard works, escalations and non-conformance are tracked to ensure prompt closure on time. Develop courses of action and drive implementation of solutions. - Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed). - Develop, manage and track the department operating budget and capital expenditure in QC system team to ensure achievement of operational targets. - Manage, develop, and motivate staff to help realized their maximum potential to contribute towards achieving the site objectives. - Uphold Pfizer's code of conduct and values. - Collaborate with cross-functional teams to drive flawless execution. - Focus on CI projects that deliver benefits. Job Related Requirements: - Effective problem solving skills. - Demonstrated leadership, innovative and strategic thinking ability and customer service skills. - Excellent verbal, written communication and presentation skills. - Comprehensive knowledge of cGMPs, GLPs and data integrity requirements for Quality Control laboratories. - Comprehensive knowledge of gLIMS, laboratory instrumentation and Empower software. - Ability to collaborate with cross functional teams to understand their expectations while ensuring compliance to quality systems and processes. - 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 degree in Science (Chemistry preferred) or Life Science relating to Chemistry, Pharmacy, Pharmaecutical Science or M