Technical QA Manager (Annex 1 Project) (m/w/d)

Randstad Switzerland; Basel; Vor Ort; CHF 90’000 - 120’000; Vollzeit

Zusammenfassung

A staffing and recruiting agency is seeking a Technical QA Manager to support the qualification of equipment in a sterile pharmaceuticals facility. The role requires at least 5 years of experience in the pharmaceutical industry and 2 years in Quality Assurance. The candidate must be fluent in German and English. This is a temporary contract scheduled until July 2026, with a focus on ensuring compliance with GMP requirements while overseeing qualification and validation activities.

Qualifikationen

• Minimum 5 years of experience in the pharmaceutical industry.
• Minimum 2 years of experience in Quality Assurance.
• Experience in equipment qualification and validation in sterile pharmaceutical manufacturing.

Aufgaben

• QA oversight of qualification and validation activities for GMP-relevant equipment.
• Support in implementing data integrity requirements.
• Review and approval of GMP documents.

Kenntnisse

Fluency in German

Fluency in English

Team player

Excellent communication skills

Influence skills

Ausbildung

Academic degree in Engineering, Chemistry, Life Science, or Pharmacy

Tools

Veeva QMS

eVAL

ELVIS

Jobbeschreibung

Technical QA Manager (Annex 1 Project) (m/w/d)

For one of our clients, a global pioneer in pharmaceuticals, we are currently looking for a Technical QA Manager to support the (re)qualification of existing and new equipment as a part of the Annex 1 project in their sterile filling facility.

General Information

• Duration: Project planned until July 2026
• Contract: Temporary contract via Randstad
• Workplace: Basel
• Remote/Home Office: On-site presence required, with the possibility of working from home by arrangement
• Working hours: Standard
• Team: 16 QA Managers
• Department: IMP Quality

Tasks & Responsibilities

• QA oversight of qualification and validation activities for GMP-relevant equipment and systems in sterile filling
• QA oversight of CSV systems
• Support in implementing data integrity requirements
• Review and approval of GMP documents (e.g., qualification plans, reports, change and deviation management, CAPAs, SOPs, risk analyses)
• Handling deviations and changes
• Collaboration with stakeholders and contributing to the achievement of shared objectives
• Representing the area of responsibility during inspections by health authorities and internal audits

Must Haves

• Academic degree in Engineering, Chemistry, Life Science, Pharmacy, or equivalent
• Minimum 5 years of experience in the pharmaceutical industry
• Minimum 2 years of experience in Quality Assurance
• Experience in equipment qualification and validation in the manufacture of sterile pharmaceuticals
• Understanding of current Data Integrity (DI) requirements
• Knowledge of global quality and GMP requirements
• Strong team player with excellent communication and influence skills
• Proven success in health authority inspections and internal GMP audits
• Fluent in German and English (spoken and written)

Nice to Haves

• Experience with Veeva QMS, eVAL, and ELVIS

Sounds interesting? Apply Now! We look forward to receiving your application.

Application Submission Deadline: 09.12.2025

Seniority level

Mid‑Senior level

Employment type

Contract

Job function

Quality Assurance, Engineering, and Project Management

Industries

Staffing and Recruiting and Pharmaceutical Manufacturing