24 Oct
|
Talental Consultings
|
India
24 Oct
Talental Consultings
India
Job Description: Deputy Manager – Production QMS (OSD)
Experience: 8–12 Years
Department: Production – OSDKey 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.
- Strong knowledge of cGMP, deviation management, CAPA, change control, and regulatory compliance.
Qualification: B. Pharmacy / M. Pharmacy
📌 Deputy Manager - Production QMS (OSD) (India)
🏢 Talental Consultings
📍 India