The primary purpose of this position is to provide leadership and direction to the QC Laboratory Data Integrity Team. The role is accountable to manage data integrity, investigation, personnel training, laboratory documentation, laboratory equipment qualification, calibration and computerized system validation and gap analysis against Pfizer Quality Standard/cGMP and all GMP-related records in QC Laboratory

How You Will Achieve It

• Drive team engagement and effective communication within QC Laboratory Data Integrity Team
• Actively coordinate with the teams to ensure the project (i.e. laboratory equipment qualification, etc.) in QC Laboratory are delivered in the most effective way and meet target dates
• Maintain and ensure compliance in Quality and Safety such as submitting CASR, QAR/ER, safety incident and CAPA as per committed in QC Laboratory
• Review and approve protocol and report of qualification of laboratory instrument
• Guide and accompany analyst during qualification of laboratory instrument
• Review computerized system validation result in the QC Laboratory 
• Perform periodic review related to audit trail, user privilege, back-up, restore and data integrity gap assessment for instrument and QC documents 
• Hold and maintain administrator account in equipment and instrument in QC Laboratory
• Maintain QC Laboratory documentation and doing Laboratory investigation, Manufacturing investigation and closure of all commitments.
• Manage calibration activities and review calibration/verification report
• Manage curricula and training assignment, and ensure training completion in QC Laboratory
• Revise SOP, STP and other GMP document in QC Laboratory, as required
• Perform training to QC Laboratory Personnel, as required

Qualifications

Must-Have

• Graduate from Faculty of Pharmacy or Chemical Science (S1, Undergraduate Degree)
• 3+ years’ experience
• Laboratory supervisory experience
• Knowledge of Good Manufacturing Practices {also cGMP} compliance requirements for Quality Control Laboratories
• Experience with leading colleagues and/or projects
• Strong people management experience
• Demonstrated skills in collaboration, attention to detail, and communication skills
• Ability to handle complex and detailed situations with a focus on quality

Nice-to-Have

• Master's degree
• Six sigma certified
• Relevant pharmaceutical experience.
• Experience with microbiological risk assessments
• Knowledge of Laboratory Information Management System Empower and Microsoft Office
• Working knowledge and understanding of requirements as it relates to method qualification and testing of components and finished products

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.