Sun Pharmaceutical Industries Ltd
Designation : QA Head
Function : QA
Functional Area : Site Quality Assurance
Job Role Summary : Managing all aspects of Quality Assurance at site including In-process QA, Quality Management System, Analytical QA, QA-Validation and Documentation. Monitor and track quality assurance metrics with site manufacturing/QC management and other cross functions. Facilitate for all time readiness of the site for any internal and regulatory agency auditsinspections at any given point of time.
Job Profile :
- Effectively manage the site Quality Assurance activities and resources necessary to smoothly run the QA operation at site.
- Assure all time readiness of site for regulatory agency inspectionsinternal audits and appropriate implementation of corrective actions regarding observations made by the agenciesinternal audit teams.
- Facilitate internal and regulatory agency audits, ensuring that findings from site audits are understood assessed and addressed site wide in a comprehensive manner.
- Responsible for batch disposition of the products.
- Responsible for ensuring availability of adequate resources, including manpower to maintain compliance with GXP requirements.
- Responsible for managing the Quality Management Systems ensuring market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timeline.
- Responsible for effective managing the change control and quality risk management process at site & ensuring all requirements of the process are adhered to and providing approvals.
- Responsible for ensuring compliance to regulatory requirements on product, process and release procedures. Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.
- Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and QA systems at the site.
Job Requirements :
- 18 to 20 Yrs of Pharma Quality Assurance experience in Formulations / OSD in a regulated Pharma site
- Experience handling regulatory and customer audits
Work / Job Experience : 18-20+ Years
Type of Experience : Pharma formulations Quality Assurance, OSD facilities
Academic Qualifications :
B.Pharm / M.Pharm
