Pharma Mgr Quality Assurance Job Opening @ Teva
Pharma Mgr Quality Assurance. M.Pharma Quality QA, Quality Job. Teva hiring Pharmacy candidates for the post Specialist.Teva Hiring Undergraduate Pharmaceutical Science candidates. Teva is a global pharmaceutical leader and the world’s largest generic medicines producer committed to improving health.
Job Title: Mgr Quality Assurance
Job Id: 6682
Location: Navi Mumbai, IN, 400706
Eligibility: M Pharma
Job Description
- Ensure that the processes needed for the Quality Management System are established, implemented and maintained at site.
- Report on the performance of the quality system to the Head-QAU for review and as a basis for improvement of the system.
- Liaison with external parties (Biopharm team) on matters relating to quality system.
- Ensure compliance to SOP, GCP/GLP and regulatory guidance’s.
- Perform Gap assessments for TEVA policies and standards and implementation of QMS at site.
- Review of raw data of respective method book, method validation, partial method
- validation study as and when assigned.
- Verify equipment installation, qualification, calibration and preventive maintenance in the laboratory is conducted as scheduled.
- Review of WinNonlin data, the statistical output of clinical study as per the requirement.
- Conduct external vendor qualification audit and review vendor agreements.
- Supervise the archiving process of documents generated by user department during the conduct of BA/BE study at site.
- Maintain and track Change Control system and track deviation and CAPA’s at site.
- Prepare plan and execute the audit of completed BA/BE studies, necessary to support the study.
- Conduct internal study audit, and system audits for compliance with GCP/GLP, Protocols, SOPs and applicable regulatory requirements.
- SDTM data review, verification and data flow from QA to SDTM team
- Support during regulatory and other inspections/audits and respond to the regulatory and sponsor’s queries at site.
- Ensure CAPA actions based on the results of the investigations are identified and implemented.
- Review/update periodically Policies, Quality Manual, Site Master File at site.
- Review and approval of Calibration, validation, re-qualification of equipment/instruments and software documentation at site.
- Review of Non-GxP and GxP computer system verification periodically at site.
- To carry out other responsibilities as and when assigned by the Head-QAU.
