QA(Validation) 4-6 Years

1 week ago

Baddi, India GMH Organics Full time

**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**:
**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

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