RA Specialist
Mumbai, IN, 400 021
Roles and Responsibilities
- Co-ordinating with manufacturers/ suppliers to fulfil the expectations of the customers
- Carrying out supplier audits/ qualifications according to cGMP/ ICH guidelines
- Coordination for closure of audit reports and follow up of CAPA
- Review of technical documents such as DMFs, etc.
- Should have good knowledge of cGMP, QMS, ISO and other industry guidelines
Requirements :
- Candidate should be B.pharm/M.pharm/M.sc
- 5-8 years relevant industry experience
- Experience in QA/ supplier qualification, audit roles.
- Willing to travel extensively in India
- Should have working knowledge and understanding of ICH, WHO, EU, US FDA, COFEPRIS.
- Familiarity with API / Formulation facilities and an understanding of their working
- Knowledge of Production and QC functions in API and finished formulations.
Skills :
- Proficient in MS word/ Excel/Power-point/ MS Teams
- Proficient in written and spoken English
- Business Communication and email etiquette
- Collaborative approach to working with internal teams and external partners.