Senior Quality Operations - Sterile Batch Release Expert

gloor & lang ag; Neuenburg; On-site; CHF 110,000 - 150,000; Full time

Job summary

Join is seeking an experienced Quality Operations professional for a 12-month assignment in French-speaking Switzerland, focusing on sterile drug product manufacturing, batch release, and product disposition within an international environment.

The role requires hands-on GMP quality work, review of deviations and CAPAs, and collaboration with external partners; you will help ensure compliance and drive continuous improvement in product quality.

Qualifications

• Bachelor's or Master's in a scientific or pharmaceutical discipline.
• Hands-on experience in Quality Operations and sterile manufacturing.
• Experience with batch review, release, and documentation.
• Knowledge of GMP, deviations, CAPAs and change controls.

Responsibilities

• Perform Quality Operations activities supporting sterile drug product manufacturing.
• Review batch documentation and support batch release / product disposition activities.
• Review and assess deviations, investigations, CAPAs and change controls.
• Ensure compliance with cGMP requirements, internal procedures and applicable regulatory standards.
• Review quality and validation documentation and identify potential compliance gaps.
• Work closely with external manufacturing partners and internal cross-functional teams to resolve quality issues.
• Support inspection and audit readiness activities.
• Maintain relevant quality and disposition information in applicable systems.
• Escalate quality or compliance risks where appropriate.
• Contribute to continuous improvement and other product quality activities.

Skills

Quality Operations

Sterile manufacturing

Batch release

Deviations & CAPAs

GMP compliance

SAP

eQMS (electronic Quality Management)

Analytical skills

English proficiency (C1-C2)

German / French language assets

Education

BSc/MSc in pharmaceutical/scientific discipline

Tools

SAP

eQMS software

Job description

Join is seeking an experienced Quality Operations professional for a 12-month assignment in French-speaking Switzerland, focusing on sterile drug product manufacturing, batch release, and product disposition within an international environment.

The role requires hands-on GMP quality work, review of deviations and CAPAs, and collaboration with external partners; you will help ensure compliance and drive continuous improvement in product quality.