Downstream QA Specialist — GMP & Compliance

Proclinical; Bezirk Solothurn; On-site; CHF 90,000 - 120,000; Full time

Job summary

Proclinical is seeking a QA Associate III to join the Integrated Downstream Quality Operations team at a large-scale manufacturing facility. You will perform QA activities for downstream operations, review GMP documents, and support deviation management and equipment qualification.

The role requires collaboration with Manufacturing, Process Engineering, and Automation SMEs to ensure compliant, high-quality products.

Qualifications

• Experience with QA activities including document reviews and deviations.
• Strong understanding of GMP standards in downstream manufacturing.
• Ability to collaborate across Manufacturing, Process Engineering, and Automation SMEs.
• Familiarity with electronic batch records and quality systems is a plus.

Responsibilities

• Perform QA activities for downstream operations and GMP manufacturing to ensure product safety and purity.
• Review and approve GMP documents including procedures, CAPAs, deviations, and change controls.
• Collaborate cross-functionally with Manufacturing, Manufacturing Sciences, Process Engineering, and Automation SMEs.
• Support monitoring and release activities for column packing/unpacking and chromatography.
• Ensure procedures are followed during GMP CAPEX and OPEX projects, shutdowns, or new product introductions.
• Participate in Quality On-Call duty rotation.
• Assist with batch record review and closure ahead of batch release.

Skills

GMP knowledge

Downstream manufacturing

QA processes

Cross-functional collaboration

Electronic batch records

Quality systems

Detail-oriented

On-call readiness

Job description

Proclinical is seeking a QA Associate III to join the Integrated Downstream Quality Operations team at a large-scale manufacturing facility. You will perform QA activities for downstream operations, review GMP documents, and support deviation management and equipment qualification.

The role requires collaboration with Manufacturing, Process Engineering, and Automation SMEs to ensure compliant, high-quality products.