QC Laboratory Compliance Supervisor – Data Integrity
Pfizer
- Jakarta
- Permanent
- Full-time
- 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
- 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
- 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