Quality Assurance Manager

Company Description

Manufacturer of dry powder injections, especially beta-lactam dry powder injections (e.g.

cephalosporins), veterinary dry powder injections, penem dry powder injections.

Role Description

This is a full-time on-site role for a QA Manager located in Ahmedabad. The QA Manager will be responsible for overseeing the quality assurance processes, ensuring that products meet company standards and customer expectations, and implementing testing procedures. The QA Manager will also lead the QA team, collaborate with other departments to resolve quality-related issues, and develop and maintain quality documentation.

• Oversee facility, equipment, and process qualification (URS, DQ, IQ, OQ, PQ).
• Ensure compliance with cGMP, FDA, WHO
• Approve validation protocols / reports (cleanrooms, HVAC, sterilizers, filling lines, lyophilizers).
• Monitor aseptic process simulations (media fills) and sterility assurance.
• Manage Validation Master Plan (VMP), deviations, CAPAs, and change control.
• Ensure container-closure integrity, cleaning validation, and powder filling accuracy.
• Lead cross-functional teams and provide GMP / aseptic training.
• Support regulatory inspections with qualification documentation.

Skills Required

OQ, Cgmp, IQ, sterility assurance , Cleaning Validation, URS, Quality Assurance