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