Manager - QA - QMS

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