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Executive RA-QA Jobs in Navi Mumbai - NiS Consultants

Executive RA-QA

NiS Consultants
experience-icon 3+ Years
salary-icon Not disclosed
Expired

Posted: 02 Dec 16

Job Description

Qualification: M. Pharm

CTC per Annum: Best in industry

Experince: 5-8 years

Responsibility:

  • Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy.
  • Timely compile materials for license renewals, updates and registrations.
  • Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners.
  • Review changes to existing products and SOPs to define the requirements for regulatory submissions.
  • Provide the regulatory reviews of customer complaints and define the regulatory reportability.
  • Responsible for timely registration of the facility.
  • Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products.
  • Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes.
  • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
  • Responsible for Contract manufacturing activities, Technology transfer of product
  • Depending on company’s requirements, above responsibilities can change and additional responsibilities may be included.

Job Particulars

Role others
Education M.Pharm
Who can apply Experienced (3+ Years)
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id253036
Job Category Others
Locality Address Navi Mumbai-Others
Country India

About Company

NiS is a Consulting firm specialized in Recruitments. We provide manpower to organizations on PAN India Basis right from junior level to senior level positions. Our aim is to provide fast, quality and cost-effective end-to-end manpower solutions for our clients. We provide premium staffing services and solutions to many companies in the fields of Finance & Accounts, Pharma & Textiles, IT & Telecom, HRD & Admin. and Senior level technical & Marketing professionals.

We work with lot of dedication and give heed to each of our client's requirements. Our sourcing team comprises of experienced people as well as vibrant youngsters. We do not depend on the portals totally it is just a window for us to reach the larger number of candidates available in the market.

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