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 [email protected] 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
Speak with the employer
+91 7876456719
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