Downstream Quality Operations Specialist III - GMP Compliance

Swisslinx; Bezirk Solothurn; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Swisslinx is seeking an Associate III – Integrated Downstream Quality Operations in Solothurn, Switzerland. You will support QA activities across downstream GMP manufacturing and equipment, collaborating with Manufacturing, Process Engineering, Manufacturing Sciences and Automation teams.

The role requires strong QA experience in GMP biotech/pharma settings, with capabilities in deviations, investigations and GMP documentation.

Qualifikationen

• Bachelor’s degree in Chemical Engineering, Bioengineering, Biotechnology, Bioprocessing, Pharmaceutical Sciences, Pharmaceutical Regulations or a related field with at least 6 years of relevant pharmaceutical/biotech manufacturing experience OR Master’s degree in a relevant field with at least 4 years of relevant pharmaceutical/biotech manufacturing experience
• Experience within a GMP pharmaceutical or biotechnology manufacturing environment
• Experience in Quality Assurance; exposure to downstream processing and equipment qualification is strongly preferred
• Experience with deviations, investigations and GMP documentation
• Understanding of downstream manufacturing operations and equipment
• Ability to work autonomously and effectively with cross-functional teams
• Strong organizational, writing, presentation and problem-solving skills

Aufgaben

• Provide QA shopfloor oversight for downstream manufacturing operations
• Review electronic batch records (eBR), electronic logbooks, LIMS records and samples
• Review and approve GMP Manufacturing and Engineering documentation
• Manage minor and major deviations and support investigations
• Support CAPAs, change controls and equipment-related quality activities
• Provide Quality oversight for equipment qualification, work orders, P&IDs, qualification protocols and calibration deviations
• Support column packing/unpacking and chromatography review and release
• Perform Quality oversight of PLM, CMMS and Kneat activities
• Participate in batch record review and close-out in preparation for batch release
• Support equipment controls and release during GMP CAPEX/OPEX projects, shutdowns and new product introductions
• Participate in the Quality On-Call rotation
• Collaborate cross-functionally to ensure compliance with applicable GMP and regulatory requirements

Kenntnisse

Quality Assurance

GMP documentation

Cross-functional collaboration

Autonomous work

Problem-solving

Project coordination

Ausbildung

Bachelor’s degree in Chemical Engineering

Master’s degree in a relevant field

Tools

LIMS

PLM

CMMS

Kneat

Jobbeschreibung

Swisslinx is seeking an Associate III – Integrated Downstream Quality Operations in Solothurn, Switzerland. You will support QA activities across downstream GMP manufacturing and equipment, collaborating with Manufacturing, Process Engineering, Manufacturing Sciences and Automation teams.

The role requires strong QA experience in GMP biotech/pharma settings, with capabilities in deviations, investigations and GMP documentation.