Pharma Quality Manager Job Opening – Teva M Pharma Job Opening
Pharma Job. Teva hiring Pharma candidates for the post.Teva Hiring Undergraduate and Postgraduate Science candidates. Teva is a global pharmaceutical leader and the world’s largest generic medicines producer committed to improving health. Check out all the details
Teva is a global pharmaceutical leader and the world’s largest generic medicines producer committed to improving health and increasing access to quality Health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day.
Job Title: Quality Manager
Qualifications
M.Pharm(QA)
M.Pharm (Pharmaceutics)
Function Quality
- Ensure that the processes needed for 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 laboratory is conducted as scheduled.
- Review of WinNonlin data, 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 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.
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