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QA TPM Specialist


  • 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

Submit your resume to
Only shortlisted candidates will be contacted. 
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