QA TPM Specialist

Responsibilities:

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.

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