Downstream QA Specialist – GMP & Batch Release

Proclinical Staffing; Bezirk Solothurn; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

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

Responsibilities include QA activities for downstream operations, document review, deviation management, and collaboration with cross-functional

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 effectively with cross-functional teams.

Aufgaben

• Perform QA activities for downstream operations, GMP manufacturing, and equipment to ensure product safety, efficacy, and purity.
• Review and approve GMP engineering and manufacturing documents, including procedures, work instructions, CAPAs, deviations, change controls, equipment work orders, P&IDs, qualification protocols, and calibration deviations.
• Collaborate with cross-functional teams during deviation management and investigations.
• Participate in monitoring and release activities for column packing/unpacking and chromatography processes.
• Ensure adherence to internal procedures during downstream manufacturing operations and equipment controls, particularly during GMP CAPEX and OPEX projects such as shutdowns, construction, or new product introductions.
• Take part in the Quality On-Call duty rotation.
• Contribute to batch record review and closure in preparation for batch release.

Kenntnisse

GMP knowledge

Cross-functional collaboration

Detail-oriented

Analytical skills

Problem-solving

Tools

Electronic batch records

Quality systems

Jobbeschreibung

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

Responsibilities include QA activities for downstream operations, document review, deviation management, and collaboration with cross-functional