Pfizer Senior QC Laboratory Manager in Tuas, Singapore
The incumbent will be responsible for overall management of the Quality Control (QC) Laboratory services and their related support teams. The incumbent will be responsible for leading, coaching and developing a team of three (3) QC Managers and their related laboratory teams ensuring that chemical and microbiological testing, data review activities and Laboratory equipment and systems on site comply with cGMP requirements and are performed in a safe and reliable manner to support manufacturing operations at the site and across all shifts.
The incumbent will ensure that the quality systems in the Laboratory are continually audited and new requirements implemented, and Good Laboratory Practices (GLPs), Good Documentation Practices (GDPs) and all related operations observe consistent compliance with current Good Manufacturing Practices (cGMPs), Pfizer Quality Standards (PQS) policies, site Standard Operating Procedures (SOPs) and regulatory guidance.
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.
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.
Responsibility of setting up and implementing QC Laboratory quality systems and strategies for developing and implementing monitoring systems to collect, collate and present information on Quality Control Laboratory for performance management and bench marking.
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.
Plan and track Quality Control objectives, timelines, priorities, and resources.
Develop, write and present business cases for equipment, staff resources and service developments.
Manage and ensure the provision of chemical and microbiological analytical services to internal/external customers to ensure that all starting materials/water samples/intermediates and final products are analyzed and tested according to the stipulated quality and regulatory requirements so as to provide accurate test results for correct GMP usage decisions.
Develop and manage the operating budget and capital expenditure proposals for the laboratory to ensure achievement of operational targets.
Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement.
Ensure that the laboratory equipment are qualified to meet regulatory standards, well maintained and in good working order.
Work closely with the relevant process owners (i.e. Production, Procurement, Supply Chain, Warehouse, Process Development) for the introduction of new starting material sources.
Through coordination with the Analytical Science & Technology (AS&T) Manager participate in the Analytical Method Transfer Exercise (AMTE) strategy from other Pfizer sites and Centre functions for new products introduced to the site.
Through coordination with the AS&T Manager participate in the development of new analytical methods for testing starting materials, process intermediates, APIs and plant cleaning samples.
Lead and/or contribute to the implementation of the site and corporate projects in line with specifications and budget allocation.
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.
Ensure the product stability programs are managed and stability data is reported for Annual Product Review Reports (APRRs) and regulatory filing in a timely manner.
Ensure laboratory automation is functional at all times and supports laboratory efficiency.
Support, promote and demonstrate Pfizer Global Supply (PGS) vision, values and leader behaviors.
Manage, develop, and motivate staff to help realize their maximum potential to contribute towards achieving the site objectives. Job Relate Requirements:
Strong knowledge of analytical chemistry, instrumentation, laboratory automation and production processes.
Thorough knowledge and understanding of GMP, GLP and analytical method validation principles.
Excellent verbal, written and interpersonal communication and presentation skills.
Demonstrated ability to interact effectively with senior management, auditors and regulators.
Demonstrated leadership, management and customer service skills.
Effective problem solving skills.
Comprehensive knowledge of cGMPs and appropriate regulations.
Comprehensive knowledge of LIMS, HPLC, GC and laboratory equipment.
Knowledge of six sigma, lean labs and standard work practices.
Experience in Empower software.
Successful track record of continuous improvement, development and/or implementation of best practices in Quality Control Laboratories. Accountabilities:
QC Laboratory operating budget and Capital expenditure.
Laboratory safety programs.
Regulatory and compliance requirements.
Analytical method development and Technology Transfer.
Operational efficiencies and CIP promotion.
Overseeing stability programs.
Standard Operating Procedure (SOPs) development and review.
Annual Product Review Reports (APRR) with respect to QC Laboratory data.
Staff development and performance review.
Annual Product Review Reports (APRR) with respect to analytical method development and validation.
Staff Development and Performance Review. Key Performance Indicators (KPIs) :
Safety performance, number of accidents/incidents, safety suggestions.
Compliance to cGMP/GLP standards, audit performance.
Laboratory testing cycle/standard testing lead times
Timely execution of laboratory projects within allocated budget and specifications.
Stability program adherence. ORGANIZATIONAL RELATIONSHIPS: The incumbent will interact with all site departments for GMP related laboratory operations and activities i.e. Manufacturing Operations Process Teams, Quality Assurance Teams, Warehouse and Tank Farm Teams and Engineering Teams. In the event of quality or regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites or Global Chemistry Manufacturing & Compliance (GCMC) teams as required in conjunction with the QA Manager.
Bachelor or Master or Ph.D. degree in Science (Chemistry preferred) or Life Sciences relating to Chemistry, Pharmacy, Pharmaceutical Sciences or Microbiology or a related science.
Familiar with the self-directed team concept; manufacturing operations applications; six sigma and lean principles and process improvement tools.
Minimum 7-10 years of technical experience in Quality Control within the pharmaceutical, food, chemical or process industries. Additional experience in Quality Assurance is highly desirable.
Minimum 5 years in a leadership/supervisory position of professional staff previously, or demonstrated capability to successfully lead large teams.
Experience in an API manufacturing plant is preferred.
Extensive knowledge of GMP compliance requirements for Quality Control Laboratories is a must.The incumbent will have the following core competencies:
Excellent Contemporary Knowledge of Analytical Techniques both theoretical and practical
Project Management skills
Team Leadership skills
Strong Analytical skills
Operational Excellence (Lean) skills
Flexi Work - Tuas (Singapore)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.