Sterile Quality Ops Senior Specialist (12-Month Temp)

gloor & lang Pharma and Biotech Recruiting; Neuenburg; On-site; CHF 95,000 - 120,000; Full time

Job summary

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

We require hands-on GMP quality experience, batch release expertise, and strong English skills (C1–C2); German or French language skills are advantageous as an asset.

Qualifications

• BSc/MSc or equivalent in a scientific or pharmaceutical discipline.
• Several years of professional experience in pharmaceutical Quality Operations / Quality Assurance.
• Hands-on experience in sterile / aseptic manufacturing is required.
• Experience with batch record review and batch release / product disposition.
• Solid knowledge of GMP quality processes: deviations, investigations, CAPAs, change controls.
• Experience with biologics drug product or External Manufacturing is a plus.
• SAP and electronic QMS familiarity is beneficial.
• Ability to work independently and learn within Quality Operations.
• Strong analytical skills and a structured, quality-focused approach.
• Excellent English (C1–C2); German or French language skills are advantageous.

Responsibilities

• Perform Quality Operations activities supporting sterile drug product manufacturing.
• Review batch documentation and support batch release / product disposition.
• Review and assess deviations, investigations, CAPAs and change controls.
• Ensure compliance with cGMP and regulatory standards.
• Review quality and validation documentation and identify potential compliance gaps.
• Collaborate with external manufacturers and internal teams to resolve quality issues.
• Support inspection and audit readiness activities.
• Maintain quality/disposition information in applicable systems.
• Escalate quality or compliance risks as needed.
• Contribute to continuous improvement and other product quality activities.

Skills

Quality Operations

Sterile Manufacturing

Batch Release

GMP Compliance

Quality Assurance

Deviations

CAPAs

SAP

Electronic QMS

Education

BSc/MSc in science or pharmaceutical discipline

Tools

SAP

Electronic Quality Management System

Job description

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

We require hands-on GMP quality experience, batch release expertise, and strong English skills (C1–C2); German or French language skills are advantageous as an asset.