Unichem Laboratories Ltd. is looking for an experienced validation officer for its API manufacturing plant at Pithampur. The candidate will be responsible for executing and coordinating validation and qualification activities to ensure compliance with applicable GMP requirements, approved protocols, and internal quality procedures.
Role & responsibilities
- Execute and coordinate process validation activities for API manufacturing processes.
- Prepare, review, and execute validation and qualification protocols and reports.
- Perform equipment qualification activities, including IQ, OQ, and PQ.
- Coordinate qualification of utility systems used in API manufacturing.
- Ensure validation activities comply with applicable GMP requirements and approved SOPs.
- Review validation data, identify discrepancies, and support investigations wherever required.
- Coordinate with Production, Engineering,
Quality Control, and other relevant departments.
- Ensure proper documentation, traceability, and timely closure of validation activities.
- Support preparation for internal audits and regulatory inspections.
- Maintain validation documentation and records in accordance with site procedures.
Key Skills Required:
Key Requirements:
- 3-5 years of relevant experience in validation/qualification within the pharmaceutical industry.
- API manufacturing plant experience preferred.
- Practical exposure to process validation and equipment/utility qualification.
- Knowledge of GMP requirements and pharmaceutical quality systems.
- Positive documentation, analytical, and coordination skills.