Associate III – Integrated Downstream Quality Operations

Job-Room; Bezirk Solothurn; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Job-Room is seeking a QA professional to provide shopfloor QA oversight for downstream manufacturing in Solothurn, Switzerland. Start as soon as possible with a 100% workload and potential extension.

You will review eBR, eLogbooks, LIMS records, and samples; review and approve GMP documentation; manage deviations and investigations; support CAPAs, change controls, and equipment qualification; oversee QC for PLM/CMMS/Kneat; participate in batch record review and release preparations; and

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 pharma/biotech manufacturing experience OR
• Master’s degree in a relevant field with at least 4 years of relevant pharma/biotech manufacturing experience
• Experience in GMP pharmaceutical or biotechnology manufacturing environment
• Experience in Quality Assurance with exposure to downstream processing and equipment qualification
• 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

QA oversight

GMP knowledge

Cross-functional collaboration

Documentation

Ausbildung

Bachelor’s degree in a related field

Master’s degree in a related field

Tools

eBR systems

LIMS

Kneat

CMMS / PLM tools

Jobbeschreibung

About the customer:

• Location: Solothurn, Switzerland
• Workload: 100%
• Start: As soon as possible
• Until: with possible extension
• Department: Quality Assurance / Integrated Downstream Quality Operations

Requirements:

• 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

Competences:

• 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

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