Senior Sterile Quality Operations & Batch Release

gloor & lang Pharma and Biotech Recruiting; Neuenburg; On-site; CHF 120,000 - 150,000; Full time

Job summary

gloor & lang Pharma and Biotech Recruiting is seeking an experienced Quality Operations professional for a 12-month temporary assignment in French-speaking Switzerland. The role focuses on sterile drug product manufacturing, batch documentation, and product disposition within an international external manufacturing environment.

The candidate will review deviations, CAPAs, and change controls, ensure cGMP compliance, and collaborate with external manufacturers and cross-functional teams to

Qualifications

• BSc/MSc or equivalent degree in a scientific or pharmaceutical discipline.
• Several years of professional experience in pharmaceutical Quality Operations / Quality Assurance.
• Hands-on experience in sterile / aseptic pharmaceutical manufacturing.
• Experience with batch record review and batch release / product disposition.
• GMP quality processes including deviations, investigations, CAPAs and change controls.
• Experience with biologics drug product and/or External Manufacturing is an advantage.
• Excellent English skills (C1–C2) mandatory; German/French an asset.

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

Quality Assurance

Aseptic manufacturing

Batch release

GMP knowledge

CAPAs & investigations

SAP

Electronic Quality Management Systems

Analytical thinking

English proficiency

Education

BSc/MSc or equivalent in science/pharma

Tools

SAP

Electronic Quality Management Systems

Job description

gloor & lang Pharma and Biotech Recruiting is seeking an experienced Quality Operations professional for a 12-month temporary assignment in French-speaking Switzerland. The role focuses on sterile drug product manufacturing, batch documentation, and product disposition within an international external manufacturing environment.

The candidate will review deviations, CAPAs, and change controls, ensure cGMP compliance, and collaborate with external manufacturers and cross-functional teams to