Senior Executive DQA | Gufic Biosciences | Indore

Job Description

Roles and Responsibilities

• To prepare, review, and implement Quality Management System related standard operating procedures.
• Ensure that processes needed for the Quality Management System are established, implemented, and maintained.
• Responsible for day-to-day tracking of non-conformances of external and internal audits.
• To take necessary follow-ups related to incidents and corrective and preventive action with the respective departments.
• Responsible for audit preparation, execution, and compliance.
• To investigate & review non-conforming events including customer complaints and internal non-conforming events.
• Ensure that a document control procedure is adopted to approve, review and update all changes to critical documents within the scope of the Quality Management System.
• Responsible to maintain the document as per current Good Manufacturing Practices.
• Responsible to prepare risk assessment documents.
• To ensure that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness.
• Responsible to initiate Change ControlDeviationIncidentNon-conformanceMarket Complaint investigation.
• Preparation and review of validation/qualification protocol & Report.
• Execution of qualification/validation activity, a compilation of report & maintenance of protocol.
• Responsible to report, review, and evaluating change control, deviation, and incident.
• Responsible for the implementation of CAPA.
• Responsible for day-to-day qualification/validation activity planning, execution, and tracking. 17. Any other responsibility assigned by the Section Head/Head of the Department

Desired Candidate Profile

Experience; 7-12 Years

Qualification; M.Pharma, MS/M.Sc(Science)