Opportunity with Pharma Company

Position : Head Quality(QA/QC)

Desired Candidate Profile :

Educational Qualification : Any Science Graduates

Preferred Industries : Pharma/Healthcare/Medical Devices/Medical Equipments

Please find the detailed Job Description :

Quality Assurance :

- To manage the team of Quality Assurance and providing them guidance on day today issues.

- To design the quality system & implementation to meet the quality objectives of an organization.

- To Prepare, review and execute the Validation Master Plan, qualification activities related to Equipment/Utility system (Steam, Compressed air, HVAC system, Water system, Media fills etc.), Facility, process and cleaning.

- To Manage the written procedures for production and process control to assure the product quality.

- To Establish the control procedure and monitoring of variation in the process to achieve the consistent process outcomes, this includes the controls on input material also.

- To Initiate, control and implement the specifications, processes, procedures to assure that the entire changes (if required) taken place through authorized procedures.

- To evaluate the customer audit findings and designing the appropriate corrective action following CAPA.

- To Handle the deviation, complaints, OOS and Vendor qualification

- To track overall quality system for effectiveness through scheduled internal audits and random checks.

- To respond the queries related to filled products in coordination with in house regulatory affairs.

- To ensure and conduct Vendor audits and compliance verification.

- To Approve the different protocols and SOP after review of its intended objective.

- To monitor the change control and deviations.

- To investigate the market complaints.

- To develop the online documentation system and making it operational.

- To handle the market complaints & recalls/returns procedures, and also responsible for batch authorization & release.

- To Conduct self inspections and external audits as appropriate.

- To provide training in all aspects of Quality Management Systems

Quality Control :

- Ensuring the GLP compliances in Laboratories.

- Prepares the laboratory for the ATR (All time Readiness) for regulatory and customer inspections.

- Responsible for the preparation of SOP's and effective implementation indepartment.

- Responsible to approve / reject the starting material, Semi finish & Finished Products.

- Responsible for plan & execute the routine analytical work of Raw material, Packing Material, Finished Material, Microbiology.

- Overall responsible for - Stability Study-, - GLP-, - Microbiological Labs- and

- Documentation Cell.

- To develop and Train Subordinates on cGMP,GLP, SOPs and on Job Training.

- Sops initiation and forwarding it for finalization to the Plant head /Q.A head. Time to time review of the SOPs and other documents and formats and make necessary changes.

- Review & approval of Calibrations & qualification of instruments.

- Responsible for initiation and review of Change Control, Deviations, Market complaint, Training, Trend analysis & OOS/OOT.

- Preparation and maintaining of monthly plan & progress report.

- Techno-commercial specification & discussion of analytical instruments.

- Quality check & compliance of internal & external audits.

- Updation of online records, documentations and analytical reports.

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.