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.

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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. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas. We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development, and innovation. This is how we improve health and enable people to live better, healthier lives. Join us on our journey of growth!

Position: Quality Analyst III

Location: Mumbai, Maharashtra

Job Description:

Job Purpose:

To manage the TPO Quality system requirements in accordance with Teva quality standards and in compliance with the regulatory requirements

  • Batch record review and disposition in a global system like SAP etc.
  • Responsible to follow the Quality Management System of TPO organization, which is relevant to the job function
  • Provide impact assessment and risk assessment for impacted CMOs, to the Regional NTM Coordinator for the GNTMs issued, after coordinating with all CMOs

Batch Record Review & Release

  • Generation of the Trackwise reports for deviations and change controls required for batch release.
  • Review and ensure that there are no open deviations and change controls impacting the release of the batches.
  • Review of the temperature reports downloaded from temperature recorders.
  • If unsatisfactory result/temperature excursion forward to the investigation team for logging the deviation in the Trackwise and ensure completion before release.

Change Controls

  • Life cycle management of change control in Global Trackwise system
  • Initiate change controls related to the batch manufacturing and packing records  specifications and analytical method of analysis  stability protocols  that are received from the CMOs
  • Evaluate the change controls for adequacy and perform line by line review of the documents QC SME for change controls that need analytical evaluation.

  • Review the method validation/verifications and method transfer reports associated with the change
  • Review process validation/qualification and other associated supporting documents required with the change

Desired Knowledge & Experience:

  • Knowledge of cGMP, Quality Management Systems, and the pharmaceutical manufacturing supply chain environment.
  • Knowledge on Compliance Standards and Regulation as applicable to the market ,
  • Experience of handling Operational Quality QA/QC exposure and External / Contract manufacturing site
  • Knowledge and working experience with USFDA / EU and other competent authority approved sites

Qualification: B. Pharm, / M. Pharm / M.Sc. (Science), B.S. Sciences

Experience: Minimum 6 – 8 years of experience in pharmaceutical industry

Salary: Negotiable

Contact Details:

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