Job Summary

We are looking for a hands-on Head – QA to lead quality assurance at our manufacturing unit. The role covers complete ownership of QA systems, documentation control, audit readiness, and batch release. The candidate should be comfortable working closely with production and QC, and capable of ensuring smooth compliance in day-to-day operations.

Key Responsibilities

• Quality Systems & Compliance

Maintain and improve QA systems in line with Schedule M / WHO-GMP

Handle

• Deviations
• Change controls
• CAPA
• OOS/OOT (as applicable)
• Ensure processes are followed on the shop floor
• Documentation Control

Review and approve:

• MFR / BMR
• STP / STS
• SOPs

Ensure proper documentation practices:

• Correct entries
• Timely updates
• Version control
• Batch Review & Release
• Review batch documents before release
• Ensure all steps are completed as per approved procedures
• Coordinate with QC and production for closure of observations
• Audit Handling

Prepare the unit for:

• Regulatory audits
• Customer / tender inspections
• Lead audits and handle queries confidently
• Close audit observations within timelines
• Cross-Functional Coordination

Work closely with:

• Production
• QC
• Stores

Ensure quality requirements are implemented without delays

• Training & Team Management
• Train staff on SOPs and QA practices
• Monitor documentation discipline across departments
• Continuous Improvement
• Identify gaps in processes and documentation
• Reduce errors, deviations, and rework

Key Requirements

Qualification: B.Pharm / M.Pharm

Experience: 8–15 years in QA (OSD/pharma manufacturing preferred)

Experience in

• Documentation review
• Batch release
• Audit handling

Required Skills

Technical

Good understanding of

• GMP requirements
• Documentation systems
• QA processes

Functional

• Strong documentation review skills
• Ability to identify errors and gaps
• Practical problem-solving

Important Note

This is a hands-on role. Candidates should be comfortable working on documents, reviewing records in detail, and coordinating closely with teams on a daily basis.

Job Type: Permanent

Pay: ₹90,000.00 - ₹125,000.00 per month

Ability to commute/relocate

• Amer, Rajasthan: Reliably commute or planning to relocate before starting work (Preferred)

Experience

• Pharmaceutical Quality Assurance: 6 years (Preferred)

Work Location: In person