- Main contact person for the third-party manufacturing and oversee the TPM operation/process.
- Responsible for implementing and maintaining the effectiveness of the Quality System.
- Support to ensure that all quality goals are met, and all practices and procedures comply with company policies, GMP principles and applicable regulations for the quality areas.
- Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments.
- Manage TPM documents, quality agreement, FMEA, ASL and TPM scorecard/KPI.
- Review, evaluate and approve all major deviations and determine the need for a corrective action. Document the deviation in the Trackwise system and perform product impact analyses.
- Review, evaluate and approve all TPM change requests for process related, commodity, raw material, SCN, QC and facilities. Initiate global change in the Trackwise system.
- Provide a constant review on the manufacturing process, equipment and facilities to assure compliance with procedures, specifications, and policies.
- Write, review and approve annual product report/product quality report.
- Actively involved in Pre-campaign activities, Post-campaign review (Track & trending program)
- Perform timely lot disposition in the SAP and LRMS/LotSmart system to meet shipment timeline and demands.
- Prepare CoA, CoC and release package for drug substance.
- Coordination of regulatory requests, including country submission, dossier review, GMP Renewal Program.
About You:
● Bachelor Degree with at least 5 years' experiences in pharmaceutical or biotech facility preferably familiar with Quality Compliance, QA Third-party manufacturing oversight and/or QA Operations.
● Knowledge of quality management system, current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in a pharma or biotech facility
● Relevant QA background from pharma or biotech environment is preferred
● Familiar with Health Authorities standards (e.g., FDA CFR and EU)
● Must be team player, meticulous, strong communication, analytical and organizational skills
