Senior QA Specialist - GMP Operations & Tech Transfer

Coopers Group

Oberwallis

On-site

CHF 120,000 - 150,000

Full time

2 days ago

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Job summary

Coopers Group in Visp seeks an experienced Quality Assurance professional to lead project-specific QA operations during commissioning and tech transfer in a GMP manufacturing setting. You will assess tasks affecting quality, coordinate with QC, Engineering and Manufacturing, and uphold SOPs and cGMP compliance.

The role requires a B.S. in Life Science, extensive pharma QA experience, and fluency in English.

Qualifications

Bachelor of Science in Life Science or related field is required.
Significant experience in pharmaceutical quality is required.
Experience in QA, Production or Engineering in pharma with cGMP; tech transfer QA is preferred.
Excellent knowledge of computer systems (TW, SAP) and risk-based quality tools (FMEA).
Fluency in English is required.

Responsibilities

Oversee project-specific QA operations during commissioning, qualification and tech transfer in Vibe-X.
Assess and manage tasks impacting quality operations during GMP manufacturing.
Coordinate with QC, Engineering and Manufacturing to plan activities.
Support day-to-day QA activities per SOPs/Policies in a GMP facility.
Review GMP records to ensure compliance with cGMP per procedures.
Make real-time process decisions on the floor following SOPs and policies.
Participate in walkthroughs, audits and inspections.