Documentation Executive- ISO 9001 & International Business

Pranay Kumar Mar 6, 2020 1115 0

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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

Employment TypeFull Time, Permanent

Role CategoryDrug Regulatory Affairs/Documentation

Education

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