About the role
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.