Glenmark Pharmaceuticals
Website:
glenmarkpharma.com
Job details:
1. Role Overview (Position Summary)
The Deputy General Manager – Quality (QMS Investigations) will lead the investigation governance framework for OOS, OOT, Deviations, Incidents, CAPA, and Market Complaints. The role ensures high-quality investigations, effective CAPA implementation, regulatory compliance, and drives cross-functional collaboration, training, data integrity, and continuous improvement to strengthen site-wide QMS maturity.
2. Key Responsibilities
- QMS Investigations Leadership
- Lead and review major QMS investigations (OOS, OOT, Deviations, Incidents, CAPA, Complaints).
- Standardize processes and ensure investigation quality.
- CAPA & Quality Assurance
- Evaluate root cause analysis and CAPA adequacy.
- Develop tools/metrics for investigation improvement.
- Score investigations using the 12‑element model.
- Audit & Regulatory Support
- Respond to audit findings and escalate critical cases to CIT.
- Cross-Functional Oversight
- Oversee QC labs, Product Development, CPP/CQA evaluation, and sample testing.
- Review manufacturing (OSD/SSD) and electronic data systems for compliance.
- Data Review & Trending
- Identify atypical trends, perform statistical analysis, and recommend improvements.
- Training & Data Integrity
- Conduct training on investigations, GDP, and Data Integrity (ALCOA+).
- Ensure documentation and data quality compliance.
- Quality Governance & Continuous Improvement
- Participate in QMR and drive site improvement projects.
- Internal Audits
- Conduct internal audits and approve audit reports.
3. Key Interfaces / Stakeholder Interactions
External: Regulatory agencies, auditors, third-party labs/vendors, CIT, consultants/SMEs.
Internal: QC, QA (Ops/Systems/Validation), Manufacturing (OSD/SSD), Product Development/R&D, Engineering, Warehouse, IT/Digital Systems, Safety, Senior Management.
4. Education, Skills & Experience Requirements
Education: B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry); preferred qualification in QA/Pharmaceutical Sciences.
Functional & Technical Skills: Strong QMS knowledge, RCA tools expertise, familiarity with CPPs/CQAs, DI/GDP knowledge, statistical analysis, documentation excellence, audit readiness, and experience with digital QMS tools.
Experience: 16–20 years in QA/QMS/QC; minimum 2 years in current Glenmark role; strong background in investigations and audits; OSD/SSD exposure.
Leadership Attributes: Strong leadership, ownership, analytical skills, communication, stakeholder management, and continuous improvement mindset.
Certifications: Six Sigma/Lean/QRM preferred; training in DI, GDP, RCA tools; knowledge of QMS platforms.
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