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Quality Sr Specialist - 6117

Date: Mar 15, 2019

Location: Bangalore, IN, 560052

Company: Teva Pharmaceuticals

Company Info

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. 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!

Job Description

  • Review of protocol against applicable regulatory guidelines.
  • Review and check of all bioanalytical documents, method validation, bioanalytical report, statistical reports and clinical study report.
  • Review of relevant standard operating procedures to check compliance with regulatory guidelines and suggest appropriate modifications if any.
  • Preparation of standard operating procedures related to Bioanalytical Quality assurance department.
  • Retrieval of documents from archives as and when required.
  • Verification of system compliance of the system with respect to the standard operating procedures and other applicable regulatory requirements and to the response to the queries.
  • Aware on various regulatory guideline such FDA,EMA,ANVISA,GCP&GLP

To carry out other responsibilities as and when assigned by the management

Qualifications

- Must be a Masters graduate in Science/M. Pharm
- Knowledgeable about QA processes in CRO environment

Function

Quality

Sub Function

R&D Quality

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.