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Deputy Manager Manager QC (QMS)
Job Location:
Monthly Salary:
Posted:
29 June 2026 (30+ days ago)
Posted:
Application Deadline:
26 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Job Description – Manager / Deputy Manager - QC (QMS)
Reports to: HOD – QC
Reports to: HOD – QC
Role Summary
Responsible for QC (QMS) activities in a biologics manufacturing facility ensuring compliance with cGMP and global regulatory standards (EMA MHRA ANVISA SFDA Health Canada).
Key Responsibilities
- Review QC raw data logbooks test records and CoA.
- Ensure cGMP compliance through routine QC audits and inspections.
- Handle QMS activities in TrackWise: Deviation CAPA Change Control Incidents OOS/OOT.
- Ensure timely investigation closure and CAPA effectiveness tracking.
- Review validation protocols/reports (method validation verification degradation studies).
- Coordinate QC training on GMP SOPs investigations and data integrity.
- SOP preparation/review in SAP S/4 HANA.
- Monitor environmental conditions (temperature & humidity) records.
- Support internal/external audits and prepare compliance reports.
- Ensure LIMS compliance and QC activity tracking.
- Assign QC responsibilities and support departmental execution.
Requirements
- Qualification: / /
- Experience: 12–20 years in QC/QMS (Biologics or Sterile Injectable plants only)
- Strong exposure to TrackWise LIMS SAP systems
- Regulatory exposure: EMA / USFDA / MHRA / ANVISA / Health Canada preferred
