Job Description
Job Summary Education : BSc / MSc Chemistry Years of Experience : 10-16 Pharma Experience Handling Of Quality Management Systems (QMS) - Preparation and Review of Quality System Standard Operating Procedures as per compliance with ISO and Regulatory guidelines. - Receipt, login, review, co-ordination, follow-ups with respective department and tracking of Change Management with impact assessment and implementation effectiveness. - Receipt, login, review, co-ordination, follow-ups with respective department and tracking of Deviation management, Laboratory Incidents with Implementation of CAPA. - Handling of OOSs, incident and OOTs through detailed investigations to establish suitable CAPA. - Coordination on Customer Complaints and Customer Returns investigation and relevant CAPA. - Handling of Internal Audits and Compliance as per ICH Q7 guidelines. - Preparation and Review of Annual Product Quality Review. - Co-ordination in CAPA. - Ensuring of Good Laboratory Practice in Quality Control department. - Review of Audit trial records and Analytical records. - Review of instrument calibration and equipment qualification documents related to QC. - Review of analytical method validation and analytical method verification documents. - Review of method edit forms and stability protocols. - Review of all logbooks and working standards. - Review of quality backup and restoration data. - Handling of reserve sample room. - Verification of samples (raw material, in-process/intermediates and finished products. - To ensure the Analyst qualification. - Handling of Deviation, Change control, OOT, OOS, Laboratory incidents, Investigations and annual trends. - Review of instrument and equipment preventive maintenance. - To review and ensure the temperature and humidity monitoring and recording of laboratory area as per the requirement. - Co-ordination on Audit related activities and relevant documents. - Responsible for verification of data with the principles of ALCOA++ as Data Integrity officer in Analytical associated activities. Skills: sop,qms,analytical method validation