Assistant Manager - QA - Validation and Qualification

Functional:

Responsible for planning, organizing, and executing qualification activity of HVAC System, Pharmaceutical Gas system and Water System.

To review the URS, design qualification, installation qualification and operational qualification protocol.

To review performance qualification protocol and report.

To plan and co-ordinate with cross-functional department for smooth execution of qualification and validation activities.

Responsible for review of technical specification of newly procured equipment and instrument w.r.t QA Validation / Qualification prospective.

Responsible review of FAT protocol and execution of FAT of new equipment and system.

Review of engineering documents ( BMS data, water system data and log books )

Team Management:

Allocate tasks and solve problems that may arise.

Create an environment of learning and support team members to realize their individual goals.

Build a culture of open communication, engagement and create an energized workplace

Must Have:

Experience of sterile injectable

Experience on qualification of sterilizers, lyophilizer, tunnel, HVAC, gas system, Air flow pattern, Smoke study, etc

Experience of electronic QMS

Team Management and work allocation