Senior Specialist Quality Assurance

Coopers Group; Oberwallis; On-site; CHF 120,000 - 150,000; Full time

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.

Skills

QA Operations

GMP

SOPs/Policies

Cross-functional coordination

cGMP knowledge

Audit & inspections

Education

Bachelor of Science in Life Science

Tools

TrackWise (TW)

SAP

Quality risk tools (FMEA)

Job description

Location: Visp

Contract start date: As soon as possible

Contract end date: 30 July 2027

Key responsibilities:

• Responsible for project specific QA Operation work during commissioning/qualification and project tech transfer in Vibe-X

• Assess and manage tasks that would impact Quality operation during GMP manufacturing

• Plan for future activities and coordinate with other departments (e.g. QC, Engineering, Manufacturing) to complete the planned activities

• Support day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for a GMP manufacturing facility

• Review GMP records to ensure compliance with cGMP per written procedures

• Make real-time decisions on process events on the floor, based on knowledge of defined SOPs & policies

• Participate in walkthroughs and audit/inspections

Key requirements:

• Bachelor of Science in Life Science or a related field

• Significant experience in the pharmaceutical quality area

• Work experience in a role in Quality Assurance, Production or Engineering, in pharmaceutical industries and cGMP controlled environment. QA experience in tech transfer is preferred

• Excellent knowledge of computer systems (e.g. TW, SAP, etc.) and quality tools such as risk based approaches (e.g. FMEA)

• Fluency in English