QC Laboratory Compliance Supervisor – Data Integrity page is loaded

QC Laboratory Compliance Supervisor – Data Integrity

Apply locations Indonesia - Jakarta time type Full time posted on Posted 10 Days Ago job requisition id 4901741

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.

Quality Assurance and Control#LI-PFE

About Us

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.

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QC Laboratory Compliance Supervisor - Data Integrity