QA - Assistant Manager (Qualification)

PeopleStrong; Daman; On-site; INR 800,000 - 1,100,000; Full time

Job summary

PeopleStrong is seeking a qualification specialist to join our validation team in India. The role focuses on developing and approving design, installation, operational, and performance qualification protocols for OSD equipment such as Rapid Mixer Granulators, Fluid Bed Dryers, and packaging lines.

You will oversee utilities qualification (HVAC, PW, compressed air, nitrogen), support the Validation Master Plan, and coordinate FAT/SAT with Engineering and vendors to ensure on-time delivery.

Responsibilities

• Prepare, review, and approve DQ, IQ, OQ, and PQ protocols for OSD equipment.
• Review FAT/SAT documents and coordinate with Engineering and vendors for successful execution.
• Oversee qualification and requalification of HVAC, PW, compressed air, and nitrogen systems.
• Assist in maintaining the Validation Master Plan and ensuring schedule adherence.

Job description

Equipment Qualification: Prepare, review, and approve Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for OSD equipment (e.g., Rapid Mixer Granulators, Fluid Bed Dryers, Compression Machines, Auto-Coaters, Blister & Bottle Packaging lines).

Utility & Facility Qualification: Oversee the qualification and periodic requalification of critical utilities, including HVAC systems, Purified Water (PW) systems, Compressed Air, and Nitrogen gas systems.

Validation Master Plan (VMP): Assist in the preparation, execution, and routine maintenance of the site's Validation Master Plan, ensuring all activities adhere to the planned schedule.

FAT/SAT Execution: Review Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) documents, coordinating directly with the Engineering team and vendors for successful execution.