Job Description

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Location Anywhere in India :  Bharuch, Mumbai, Pune, Baddi, Ahmedabad, Anand, Vadodara

Roles and Responsibilities 1) Computerized System Validation (CSV) Associate or Analyst Job Profile: The responsibilities will include developing validation documentation and support for computerized systems used in GLP, GMP and GCP environments. Validation documentation will encompass validation plans, specifications, test protocols and standard operation procedures. Systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure. Candidates are required to have at a minimum a bachelors degree in engineering / science. 1 - 6 years of work experience is a must. Candidates must have experience/exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. Good communication and technical writing skills are a must.2) Validation Specialist or Engineer Job Profile Working on validation and compliance projects for clients. The projects will include developing validation documentation for pharmaceutical and biotechnology equipment, facilities and computerized systems used in GLP, GMP and GCP environments. Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Pharmaceutical and Biotech Manufacturing Equipment, Facilities, Utilities, and Process Automation. Bachelors degree in engineering / science. 2-4 years of work experience is a must. Experience/exposure to Equipment Validation, Facility Validation and GAMP 5.Good communication and technical writing skills are a must. Job Location Our Office is located in Bangalore and the job may involve travel to client locations.

Role : Documentation/Medical Writing

Salary: Not Disclosed by Recruiter

Industry: Pharma, Biotech, Clinical Research

Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology

Role Category: Drug Regulatory Affairs/Documentation

Employment Type: Full Time, Permanent

Skills Required: Documentation,Clinical Research,Biotechnology,Medical,Pharmaceuticals,Medical Writing,Drug Regulatory Affairs