Responsibilities:

• 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

Skills

• Have knowledge of analytical instruments like HPLC, LCMS etc.
• Have basic knowledge of calibration process of instruments.
• Knowledge of cGMP, GLP, GDP & QM