Quality Assurance Specialist
vor 1 Woche
QA Associate (M/F/D)
Tasks:
- Handling of shopfloor oversight over the manufacturing operations, eBR and elogbook review (LIMS and samples, QRMs…) (60%)
- Executes QA activities related to downstream operations, GMP manufacturing, and downstream equipment to ensure the safety, efficacy and purity of the products manufactured.
- Reviews and approves GMP Engineering and Manufacturing documents during both project and operational phases of the site, specifically related to procedures, work instructions, CAPAs, deviations, change control, equipment (work orders, P&IDs, qualification protocols, calibration deviations..,) etc.
- Partners with Manufacturing, Manufacturing Sciences, Process Engineering, Automation SMEs during deviation management and investigations.
- Take part to the monitoring and release activities for Column Packing / Unpacking and Chromatography Review.
- Ensures adherence to internal procedures during downstream manufacturing operations or for equipment controls and release before and during GMP CAPEX and OPEX project (i.e., shutdowns, construction projects) or New product introduction.
- Take part of the Quality On-Call duty rotation for Quality.
- Participates in batch record review and close out in the view of batch release.
Qualification:
- Bachelor's degree in relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 6 years of experience in pharmaceutical or biotech manufacturing environment.
- Master's degree in relevant field such as Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations and at least 4 years of experience in pharmaceutical or biotech manufacturing environment.
- Experience with Quality Assurance, Equipment Qualification, Downstream Process is preferred.
- Demonstrated ability to work autonomously with cross-functional team members.
- English B1 as a minimum.
Requirements:
Start: 01.04.2025
Duration: 6 months
Location: Greater Solothurn Area
Seniority level: Associate
Employment type: Full-time
Job function: Analyst and Manufacturing
Industries: Pharmaceutical Manufacturing
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