Location: Bangalore, India
Company: Teva Pharmaceuticals
Job Id: 40103
Who are we?
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
- Aware on GCP,GLP ,FDA,EMA guideline requirement specific to BA/BE study conduct
- Management of log books and forms.
- Review of protocol against applicable regulatory guidelines and applicable SOPs.
- Preparation ,review of relevant standard operating procedures to check compliance with regulatory guidelines and suggest appropriate modifications if any.
- Retrieval and archival of documents as and when required.
- Review and distribution of bioanalytical methods, validation protocols, bioanalytical protocols and standard operating procedures.
- Review of documents and ensure compliance with respect to the validation and calibration of analytical instruments and software as per standard operating procedure and validation master plan.
- To perform scheduled internal audits, vendor audits, external monitoring, remote audits, facility audits and to ensure if they are completed as per the schedule.
- To facilitate quality council/quality review meeting with user team.
- To support during regulatory inspections and sponsor audits.
- To ensure the procedures of projects conducted comply with all the applicable principles of GLP, study protocol, In-house SOPs and other applicable regulatory requirements (Method development till the study document submission).
Qualifications
- 2+ Years
- Educational Qualifications – Msc / M.Pharma
Function
Quality
Sub Function
R&D Quality
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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.