Sr. Officer/Executive/ Sr. Executive
Responsibilities
- Ensure that deviations and planned changes are handled as per the established systems and are authorized by the responsible persons.
- Handle Out of Specification (OOS) and handle of Out of Trend (OOT) logging, investigations and closure.
- Handle change controls.
- Review, evaluation and approval of change control raised at site.
- Tracking and closure of change controls.
- Prepare, review and closure of Quality Risk Assessments.
- Coordinate with all technical departments at the manufacturing site for QMS related activities/queries.
- Support regulatory affairs department for QMS related activities/queries.
- Ensure regulatory compliance w.r.t QMS commitments.
- Storage and maintenance of documents / records generated as per cGMP requirements.
Requirements
- Experience : 4 - 8 Years Experience working in Quality Assurance.
- Qualification : - M.Sc, B.Pharm, B.Tech (Biotechnology).
Experience
