Job Description

Key Responsibilities:

Execute and review validation protocols (IQ/OQ/PQ) for equipment, utilities, and systems used in sterile injectable manufacturing. Perform process validation, cleaning validation, and hold time studies. Prepare, review, and maintain validation-related documents as per cGMP and regulatory requirements. Coordinate with cross-functional teams including Production, QC, Engineering, and Regulatory Affairs during validation activities. Participate in qualification of HVAC, WFI, PW, compressed air systems, autoclaves, and filling line equipment. Support regulatory audits (EU, WHO, etc.) and provide necessary validation documentation. Ensure compliance with data integrity and good documentation practices.

Qualifications:

B.Pharm / M.Pharm / M.Sc in a relevant field. 4-6 years of experience in QA Validation within a sterile/injectables manufacturing environment. Strong understanding of regulatory guidelines ( MHRA, EU GMP). Proficient in documentation, protocol writing, and deviation/investigation handling. Good interpersonal and communication skills.

Preferred Skills:

Experience with aseptic processes and cleanroom validation. Familiarity with computerized system validation (CSV). Knowledge of risk assessment tools like FMEA.

Employment Type:

Full-Time

Work Location:

Baddi( Jharmajri)

Salary:

30000 to 45000

To Apply:

Please send your updated CV to rahul@gmh.co.in or WhatsApp 7876456719

Job Types: Full-time, Permanent

Pay: ₹30,000.00 - ₹40,000.00 per month

Benefits:

Cell phone reimbursement Flexible schedule Food provided Health insurance Internet reimbursement Leave encashment Life insurance Paid sick time Paid time off Provident Fund
Work Location: In person