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Experience HELM as a unique family business and an attractive employer. Through a constant exchange of ideas, our ultimate goal is to offer our customers future-oriented solutions within our global network. At any time, in any place. This allows us to work proactively and think long-term - in operations, quality management, process optimization, product development and distribution. We are innovation drivers, possibility makers and a reliable partner, all in one.

RA Specialist

Date:  Apr 2, 2025
Location: 

Mumbai, IN, 400 021

Business Unit:  Pharma
Job Function:  Product Development / Launch Management
Level of Experience:  Mid-Career

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.

Every day, each one of us contributes to HELM's success with competence, the highest expertise and unique service. We reward this commitment - not only with international opportunities, possibilities for seminars and further training but also with benefits that offer optimal conditions to reach the perfect work-life balance.

Interested?
Then please apply with all necessary documents via our application portal.

Apply now »