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.