Job description

To provide direct support to the QMS Lead in the management of the day to day aspects to ensure effective Quality System Implementation at Madurai Manufacturing Facility. The position will be responsible for QMS related documentation, support in all audits and projects.

Primary Responsibilities
•    Responsible for planning and monitoring of day-to-day activities of Quality System in the plant.
•    Preparation and implementation of Quality System SOPs,and WI instructions.
•    Prepare and regular updation of Quality Manual, Site Master File and related policies or procedures.
•    Support Manufacturing and other teams to prepare and implement the Equipment and General SOPs.
•    Review and control of SOPs, STPs, Specifications, Batch production records, Log registers and raw data sheets.
•    To conduct quality related trainings.
•    Register Change control, Deviation, OOS, CAPA, Quality Risk Assessment and Market complaints.
•    Track and trend CAPA, change controls, deviations, quality system documents and implementation of the same.
•    Responsible for preparing the Annual Product review for all products.
•    To conduct Self inspections and archival of its reports.
•    To provide support in audits.
•    Facilitating sharing of best practices including global standards.
•    To review the executed Batch production records for product release.
•    To investigate the product recalls/complaint report and implementation of CAPA.
•    Overall responsible for the issue and archival of all types of Quality documents of plant.
•    Prepare the monitor the Quality Matrix for the plant.
•    In-depth understanding of regulatory requirements, exposure to all the regulatory guidelines and first hand exposure to regulatory audits.

Supporting Responsibilities
•    Ensure support in execution of any Quality oriented project assigned by Lead / Head Plant Quality Operations from time to time.
•    Support Lead / Head Plant Quality Operations for tracking & meeting established department and project goals and budgets