Department: Quality Assurance

Qualification: B.Pharm / M.Pharm / M.Sc (Chemistry, Microbiology or related life sciences)

Job Summary

We are looking for an experienced Quality Assurance qualified to lead QA operations at our pharmaceutical manufacturing site. The role ensures that all systems, processes and records comply with Schedule M, cGMP and international regulatory expectations, and that the site is always inspection-ready.

Key Responsibilities

Compliance and Data Integrity

- Ensure compliance with Schedule M, cGMP and data integrity principles (ALCOA+) across all systems and records.
- Review and approve SOPs, specifications, protocols and reports, and ensure the document control system is followed across the QA section.

Audits and Inspections

- Lead preparation for regulatory and customer audits (WHO, US FDA, MHRA, EU-GMP) and act as the point of contact during inspections.
- Plan and lead internal audits and self-inspections, and ensure timely closure of observations with effective CAPA.

Quality Systems

- Oversee change control, deviation, OOS and OOT investigations, approve root cause analysis and CAPA, and monitor effectiveness checks.
- Oversee complaint, recall and market return investigations, including regulatory reporting decisions and trend analysis.

Validation and Qualification

- Review and approve validation and qualification protocols and reports (process, cleaning, equipment, utilities, analytical methods).
- Coordinate validation activities with Production, QC, Engineering and other departments.

Vendor and Contract Manufacturer Management

- Qualify and monitor vendors and contract manufacturers, including review of audit reports and quality agreements.

Product Quality Review

- Review and approve in-process,



finished product and stability data.
- Resolve quality issues raised by the shop floor and support batch release decisions.

Required Qualification and Experience

- B.Pharm / M.Pharm / M.Sc.
- 5 to 10 years of QA experience in a pharmaceutical formulation or API plant.
- Hands-on experience with regulatory or customer audits.

Key Skills

Technical Skills

- Strong knowledge of Schedule M, cGMP, WHO-GMP, US FDA, MHRA and EU-GMP requirements
- Data integrity (ALCOA+) and computerized system compliance
- Change control, deviation, OOS/OOT, CAPA and root cause analysis (5 Why, Fishbone, FMEA)
- Validation and qualification (IQ/OQ/PQ, process and cleaning validation)
- Vendor qualification, quality agreements and audit report review
- Complaint, recall and market return handling
- Stability data review and document control (SOPs, specifications, protocols)

Soft Skills

- Strong leadership and team management
- Clear written and verbal communication
- Sound decision-making and attention to detail
- Cross-functional coordination and problem-solving
- Ability to stay calm and confident during inspections

Preferred Candidate Profile

- B Pharm / M. Pharm or MSc candidates with a regulated-market background (preferred, not mandatory)
- Has faced at least 2 to 3 regulatory or customer audits (WHO, US FDA, MHRA, EU-GMP) and handled observation responses
- Experience closing audit observations with effective CAPA
- Currently working at a Sr. Executive / Asst. Manager level in a reputed pharma company
- Working knowledge of QMS software (e.g., TrackWise, MasterControl) and MS Office
- Good analytical mindset with a proactive, inspection-ready approach
- Stable career record and willingness to join at short notice

📌 Manager / Sr. Manager, Quality Assurance (Pharma) (Vadodara)
🏢 RENOWN PHARMACEUTICALS
📍 Vadodara