We are looking for an experienced QA professional with knowledge of equipment qualification and validation in the pharmaceutical industry, preferably in sterile or injectable manufacturing. The candidate will be responsible for ensuring that equipment and processes meet GMP standards and regulatory requirements.
Key Responsibilities
- Prepare and review equipment qualification documents such as URS, DQ, IQ, OQ and PQ.
- Handle equipment qualification and validation activities.
- Prepare and maintain validation protocols and reports.
- Ensure compliance with GMP guidelines, SOPs and quality standards.
- Coordinate with QA, QC, Production and Engineering teams.
- Handle deviations, CAPA and change control documentation.
- Support internal and external audits.
- Conduct risk assessments and periodic equipment reviews.
- Maintain proper validation records and documentation.
Required Skills
- Knowledge of Equipment Qualification and Validation.
- Hands-on experience with IQ, OQ, PQ, URS and DQ.
- Understanding of GMP and pharmaceutical quality standards.
- Knowledge of validation documentation and risk assessment.
- Experience in Deviation, CAPA and Change Control.
- Knowledge of RM Testing, Specifications (SPEC) and COA.
- Experience in sterile or injectable manufacturing will be preferred.
Qualification
B.Pharm / M.Pharm / B.Tech / M.Tech or equivalent qualification.