Documentation Executive- ISO 9001 & International Business

Documentation Executive- ISO 9001 & International Business
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Documentation Executive- ISO 9001 & International Business

3B BlackBio Biotech (I) Ltd.

1 - 5 years

₹ 1,25,000 - 5,00,000 P.A.


Job description

  • Prepare, Organize and maintain documents and records
  • Coordinate with respective teams including external consultants to implement quality system and regulatory compliance
  • Plan and manage periodic internal audits
  • Manage non-conformance, corrective action, preventive action and deviation
  • Provide guidance regarding best practices and continuous improvement
  • Establish effective processes for handling CAPA resulting from customer complaints/ feedback

Required Candidate profile


  • Having understanding of Quality Management System- ISO 9001:2015, ISO 13485:2016, GMP, CE marking, FDA & Medical Device Regulation & International Business Documentation
  • Risk Management understanding
  • Work experience in Quality control / Assurance /Regulatory in diagnostics industry or medical device manufacturing


Perks and Benefits

Best in the industry

RoleDocumentation/Medical Writing

Industry TypeMedical Devices / Equipments

Functional AreaMedical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Employment TypeFull Time, Permanent

Role CategoryDrug Regulatory Affairs/Documentation


UG :B.A in Any Specialization, B.Com in Commerce, Any Graduate in Any Specialization, B.Pharma in Pharmacy, B.Sc in Any Specialization

PG :Any Postgraduate in Any Specialization

Recruiter Details :

Shirish Anand Koshti

Company Recruiter at 3B BlackBio Biotech (I) Ltd.