Quality Assurance Assistant Manager/DM in Sterile Formulations

4 days ago


Perungudi, India Regenix Biosciences Ltd Full time

Job Summary:

The QA Assistant Manager – Sterile Formulation is responsible for supporting the implementation and maintenance of quality systems and procedures in compliance with cGMP, regulatory requirements, and internal policies. The role focuses on ensuring the quality and sterility of parenteral products by overseeing documentation, validation, aseptic practices, and regulatory compliance activities.

Experience : 10+years in sterile formulation

Salary Based On Experience

Job Description:

10+ years experienced sterile IPQA/Validation candidates with exposure in below areas,

  • Responsible for validation master plan and handling of Equipment/instrument qualifications.
  • Preparation/review of URS, FAT, SAT, IQ, OQ, PQ protocols/reports for new equipments/instruments.
  • Preparation/review of Process validation protocol & reports.
  • Preparation/review of cleaning validation protocol & reports.
  • Managing shopfloor IPQA/line clearance/Sampling during batch manufacturing/packing.

Job Types: Full-time, Permanent

Pay: Up to ₹50,000.00 per month

Benefits:

  • Health insurance
  • Paid sick time
  • Provident Fund

Education:

  • Bachelor's (Preferred)

Experience:

  • Quality assurance in sterile formulation: 10 years (Required)

Work Location: In person



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