Senior QC Lab Manager

Responsibilities

• Ø Responsible for developing and managing integrated Quality Systems and providing technical support and advice on Quality Control matters to other areas within the site: Production, Procurement, Supply Chain, Warehouse, and Process Development.
• Ø Responsibility for QC personnel management, QC project management, and ensuring that quality risks associated with the QC Laboratory operations are correctly assessed, identified and managed.
• Ø Plan and track Quality Control objectives, timelines, priorities, and resources.
• Ø Develop, write and present business cases for equipment, staff resources and service developments.
• Ø Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
• Ø Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement. Perform investigation related to EHS (as needed).
• Ø Ensure that the laboratory equipment are qualified to meet regulatory standards, well maintained and in good working order.
• Ø Work closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
• Ø Lead and/or contribute to the implementation of the site and corporate projects in line with specifications and budget allocation.
• Ø Promote use of Right First Time (RFT) methodologies and root cause analysis tools for analytical trouble shooting, safety and Continuous Improvement Projects (CIP). Using Statistical Process Control (SPC) methodologies for improving efficiencies and cost.
• Ø Ensure the product stability programs are managed and testing data (including stability data) is reported for Annual Product Review Reports (APRRs) and regulatory filing in a timely manner.
• Ø Ensure laboratory automation is functional at all times and supports laboratory efficiency.
• Ø Support, promote and demonstrate Pfizer Global Supply (PGS) vision, values and leader behaviors.
• Ø Manage, develop, and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives.
• Ø Uphold Pfizer's code of conduct and values.
• Ø Play an active and impactful role in Tier processes by updatingperformance against metrics, highlighting & resolving issues, with appropriate escalations. Develop courses of action and drive implementation of solutions.
• Ø Collaborate with cross-functional teams to drive flawless exe

Benefits

Additional Information

The incumbent will be responsible for overall management of the Quality Control (QC) Laboratory services and their related support teams. With extensive knowledge of compliance requirements relating to the QC function together with excellent verbal, written, and interpersonal communication skills the incumbent will need to be action-orientated, agile with respect to change management and a strong leader for the quality culture of the Laboratory and the site to achieve the site Quality Control operational objectives. Key accountabilities include: Lead, coach and develop a team of QC Managers, supervisors and their related laboratory teams ensuring that analytical (physical, chemical and microbiological) testing, data review activities and Laboratory equipment and systems on site comply with site Standard Operating Procedures (SOPs) and are performed in a safe and reliable manner to support manufacturing operations at the site and across all shifts. Ensure that the quality systems in the Laboratory are continually audited with new requirements implemented and all QC related operations 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.

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