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Validation and QA Specialist at Millipore S.A.S.

Bangalore, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

02 May, 26

Salary

0.0

Posted On

01 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation, Quality Assurance, cGMP, GAMP 5, FDA Regulations, Risk Assessments, Cleanroom, Equipment Oversight, Manufacturing Processes, Testing Processes, IQ/OQ/PQ Protocols, Computer System Validation, Collaboration, Audits, Compliance

Industry

Biotechnology Research

Description

Your Role: As a Quality Validation Expert, you will be responsible for identifying, planning, and implementing validation requirements in a cGMP environment. This includes overseeing cleanroom, equipment, instruments, and manufacturing/testing processes in a Green Field Pharma facility. You will prepare and execute IQ/OQ/PQ protocols, coordinate computer system validation, and ensure compliance with applicable standards. Who You Are: Minimum Requirements: Master of Science (Life Science) from a reputed institution or B.Tech or Engineering background. Minimum of 8 years of experience, with at least 5 years in quality assurance within reputed pharmaceutical industries or research institutes. Maximum Requirements: Develop and maintain the validation master plan (VMP). Conduct risk assessments and ensure compliance with cGMP, GAMP 5, and FDA regulations.Collaborate with Quality, Production, Engineering, and IT teams to drive validation and quality assurance deliverables. Participate in internal and external audits and respond to findings related to validation.

Responsibilities

As a Quality Validation Expert, you will identify, plan, and implement validation requirements in a cGMP environment. You will oversee cleanroom, equipment, instruments, and manufacturing/testing processes in a Green Field Pharma facility.