QA - Executive
- Responsible for framing, controlling and issuance of Standard Operating Procedures (SOPs) and guidelines for all the key operations across various functions at site.
- To ensure the issuance/archival & retrieval of documents.
- To plan & execute the internal quality audit & documentation/data review as per the defined frequency
- To Record the key/live observations during the actual audit
- To investigate the cause of any non-conformance & its corrective/preventive action.
- Guiding the team(s) the ways in which they can reduce the noncompliant observations
- Publishing reports, observations and the corrective as well as preventive actions discussed/suggested/taken
- To ensure the proper archival & storage of final compounds & intermediates as per the defined process
- Maintaining master files/documents/registers (hard/soft).
- Maintaining through record of all its activities and observations.
- Conducting regular and surprise personal inspections to monitor effectiveness of the implemented QMS
- Have knowledge of analytical instruments like HPLC, LCMS etc.
- Have basic knowledge of calibration process of instruments.
- Knowledge of cGMP, GLP, GDP & QM