QA Associate

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

Join our client and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.

Proclinical is seeking a QA Associate III to join the Integrated Downstream Quality Operations team at a large-scale manufacturing facility. In this role, you will focus on quality operations and engineering activities related to downstream manufacturing and equipment. This position involves ensuring compliance with GMP standards and supporting the production of safe, effective, and high-quality products.

Responsibilities:

• 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, including Manufacturing, Manufacturing Sciences, Process Engineering, and Automation SMEs, 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.

Key Skills and Requirements:

• Strong understanding of GMP standards and downstream manufacturing processes.
• Experience with quality assurance activities, including document review, deviation management, and equipment qualification.
• Ability to collaborate effectively 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.

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