Validation and QA Specialist 1
BengaluruFull-time6–11 yrsPosted 3 weeks ago
Senior QA and testing role at Merck KGaA (MilliporeSigma / EMD) in Bengaluru. Needs 6+ years and a B.Tech or B.E..
About the role
Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.
What you'll do
- Identify, plan, and implement validation requirements across equipment, instruments, utilities, and manufacturing/testing processes in a cGMP greenfield facility
- Coordinate and support cleanroom qualification, facility and utility qualification activities; create and govern the Validation Master Plan (VMP); review, approve
- Identify and assess validation changes, deviations, and CAPAs; ensure remediation and closure of compliance actions; conduct risk assessments (FMEA, impact assessments)
What you need
- FMEA
- HVAC
- GMP
- ISO 9001
- SOP writing
- Root cause analysis
Good to have
- Safety management