QA - Assistant Manager (Qualification)

USV PRIVATE LIMITED; Daman; On-site; INR 600,000 - 1,200,000; Full time

Job summary

USV PRIVATE LIMITED is seeking a qualified professional to lead equipment and utility qualification activities across OSD manufacturing lines, including Rapid Mixer Granulators, Fluid Bed Dryers, packaging lines. You will prepare, review, and approve DQ/IQ/OQ/PQ protocols and reports to ensure compliant validation deliverables.

The role involves coordinating FAT/SAT, maintaining the Validation Master Plan, and working with engineering and vendor teams to keep schedules and documentation up to

Qualifications

• Prepare, review, and approve DQ/IQ/OQ/PQ protocols and reports for OSD equipment such as Rapid Mixer Granulators, Fluid Bed Dryers, Compression Machines, Auto-Coaters, and packaging lines.
• Oversee qualification of critical utilities including HVAC, PW systems, compressed air, and nitrogen.
• Assist in the site Validation Master Plan preparation and routine maintenance.

Responsibilities

• Review FAT/SAT documents and coordinate with Engineering and vendors for successful execution.
• Coordinate qualification activities to ensure adherence to schedules and regulatory requirements.

Skills

Equipment qualification

Utility qualification

Validation Master Plan

FAT/SAT coordination

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.