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QA Associate, Solothurn
vor 4 Wochen
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Proclinical is seeking an Associate III to join the Integrated Downstream Quality Operations team. This role involves engaging in quality operations and engineering activities for downstream manufacturing and equipment at a large-scale facility. The focus is on ensuring product safety, efficacy, and purity through comprehensive quality assurance practices.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Execute QA activities related to downstream operations and GMP manufacturing.
- Review and approve GMP Engineering and Manufacturing documents, including procedures, work instructions, CAPAs, deviations, and change control.
- Collaborate with cross-functional teams during deviation management and investigations.
- Participate in monitoring and release activities for Column Packing/Unpacking and Chromatography Review.
- Ensure adherence to internal procedures during manufacturing operations and equipment controls.
- Engage in batch record review and closeout for batch release.
Key Skills and Requirements:
- Bachelor's or Master's degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, or related fields.
- Experience in pharmaceutical or biotech manufacturing environments.
- Familiarity with Quality Assurance, Equipment Qualification, and Downstream Processes.
- Ability to work autonomously and collaboratively with cross-functional teams.
- Strong presentation, organizational, and writing skills.
- Problem-solving capabilities.
- Proficiency in English at a B1 level or higher.
