Job Description: Deputy Manager – Production QMS (OSD)
Experience: 8–12 Years
Department: Production – OSD
Key Responsibilities
Ensure implementation and compliance with cGMP SOPs and regulatory requirements in OSD manufacturing.
Manage Production QMS activities including deviations investigations CAPA change controls and incident reporting.
Review and ensure accuracy of Batch Manufacturing Records (BMRs) Batch Packaging Records (BPRs) and other production documents.
Coordinate with QA QC Engineering and other cross-functional teams for timely closure of quality events.
Conduct root cause analysis using appropriate investigation tools and ensure effective CAPA implementation.
Support internal audits customer audits and regulatory inspections including USFDA and other regulatory agencies wherever applicable.
Monitor recurring deviations documentation errors and process non-conformances; drive preventive actions.
Ensure SOP preparation revision periodic review and implementation within the Production department.
Support change management risk assessments and quality improvement initiatives.
Ensure training and GMP awareness of production personnel.
Maintain data integrity and valuable documentation practices (GDP) in all manufacturing activities.
Prepare and monitor QMS-related metrics including deviation closure timelines CAPA effectiveness and audit observations.
Candidate Profile:
Relevant experience in Production QMS within OSD formulations manufacturing.
Solid knowledge of cGMP deviation management CAPA change control and regulatory compliance.