Downstream QA Specialist - GMP Compliance & Release

Proclinical Group; Bezirk Solothurn; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Proclinical Group is seeking a QA Associate III to join the Integrated Downstream Quality Operations team at a large-scale manufacturing facility. You will focus on quality operations and engineering activities related to downstream manufacturing and equipment, ensuring GMP compliance and producing safe, high-quality products.

The role involves document review, deviation management, batch release support, and collaboration with Manufacturing, Process Engineering, and Automation SMEs.

Qualifikationen

• Strong understanding of GMP standards and downstream manufacturing processes.
• Experience with QA activities including document review, deviation management, and equipment qualification.
• Ability to collaborate with cross-functional teams.
• Familiarity with electronic batch records and quality systems is a plus.
• Detail-oriented with strong problem-solving and analytical skills.
• Willingness to participate in on-call rotations as needed.

Aufgaben

• Perform QA activities for downstream operations and GMP manufacturing.
• Review and approve GMP documents: procedures, CAPAs, deviations, change controls.
• Collaborate with cross-functional teams on deviations and investigations.
• Support monitoring and release of column packing and chromatography.
• Ensure adherence to procedures during GMP CAPEX/OPEX projects.
• Participate in Quality On-Call duty rotation.
• Assist batch record review and release preparation.

Kenntnisse

GMP knowledge

Downstream manufacturing

Deviations management

Equipment qualification

Cross-functional collaboration

Electronic batch records

Problem solving

On-call readiness

Jobbeschreibung

Proclinical Group is seeking a QA Associate III to join the Integrated Downstream Quality Operations team at a large-scale manufacturing facility. You will focus on quality operations and engineering activities related to downstream manufacturing and equipment, ensuring GMP compliance and producing safe, high-quality products.

The role involves document review, deviation management, batch release support, and collaboration with Manufacturing, Process Engineering, and Automation SMEs.