Manager -QA

Aarti Pharmalabs Ltd has an opportunity for Manager QA role at Atali Location:

Please find below the JD :

*To monitor the implementation of quality management systems in all the departments.

* To ensure appropriate documentation and fulfillment of statutory requirements with regard to regulatory authorities. To review and give authorization for QMS related documents like SOPs, validation and qualification protocol and reports, Deviations, Change control, CAPA, Market complaints, Product Quality Review, Vendor documents, Batch documents, Risk assessment etc. *To review and approve the Nitrosamine assessments for the product manufactured at site.

To investigate the failures, market complaints and returned products.

* To investigate the out of specification and Out of trend results. To evaluate and approve the deviations and change controls.

*To Approve and Release the batch for sale after the satisfactory evaluation of the Batch record and the analytical data.

* To evaluate and approval of the CAPA wherever required.

* To arrange and conduct training on cGMP, Data integrity and ethical conduct. To monitor the calibration and preventive maintenance program.

* To provide guidance and monitor the activities carried out in the Microbiology laboratory. To provide the guidance and monitor the activities carried out in the IPQA section (QC laboratory). *To monitor the stability study/ hold time study program.

*To coordinate and conduct internal audits as per schedule.

*To coordinate validation activities at the site.

*To coordinate and conduct the Management review meeting as per schedule.

*To coordinate during the customer and regulatory inspections.

*To provide response to the customer complaints and queries.

*To arrange and conduct audits of raw/packing material vendors, contract laboratory, and contract manufacturers etc.

Overall responsible for manpower planning and performance appraisal for quality assurance, Microbiology Laboratory, IPQA section and Information technology department.

*Should have worked in the USFDA approved organizations and well aware of all the regulatory requirements in accordance to the respective guidelines.

Candidate from CDMO/API intermediate would be preferred.

Interested candidates can share their updated resume on 'jyotsna.sable@aartipharmalabs.com'