Manager – Research Quality Assurance @ Sun Pharma | Apply Now

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Sun Pharma an international,specialty pharmaceutical company headquartered in India with a global manufacturing network across 25 countries. We manufacture and market a large basket of pharmaceutical formulations as branded generics & generics in India, US and across the world. Our leadership is approachable, encourages transparency & strong work ethics to ensure that people get the best opportunities to learn and grow. We encourage our employees to challenge themselves for highest level of performance through greater bandwidth of work responsibilities and growth opportunities. Apply to us if you wish to be part of Sun Pharma growth story.

Job Title – Manager – Research Quality Assurance

Experience – 5 – 10 Years

Location – Vadodara

Job Description

1. Review of Raw data and report of Bio-analytical phase of bio
study, Preclinical study, CTD, Method Validation, Partial Method
Validation, Study protocol and other related documents.
2. To perform audits like In-process audits, System/Facility/Process
based audits.
3. Review of study templates, Method validation templates, SOP,
Analytical Test Procedures, change control, Incident and deviation,IQ, OQ, PQ.
4. CRO and Clinical trial site evaluation/qualification related to bio
analytical activities.
5. Outsourced study report review.
6. Review of Pharmacokinetics and Toxicokinetics analytical report.
7. Regulatory query response review.

Desired Profile:
  • UG -B.Sc – Any Specialization, B.Pharma – Pharmacy
  • PG – MS/M.Sc(Science) – Any Specialization, M.Pharma – Pharmacy

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