Senior QA & FvP Specialist for Swiss Pharma (8 months)

Worklane GmbH; Zug; Vor Ort; CHF 110.000 - 160.000; Vollzeit

Benefits dieser Stelle

25 days annual leave

Company pension contributions

Fitness subsidy

Zusammenfassung

Worklane GmbH in Zug, Switzerland, seeks an experienced Technical Responsible Person (FvP) / Senior QA for an 8‑month temporary assignment to lead the QMS, ensure GMP/GDP compliance, and perform batch release activities for the Swiss market.

You will collaborate with internal and external stakeholders, maintain registrations, support pharmacovigilance, and uphold high standards of quality and regulatory compliance. German C1 and fluent English are required.

Qualifikationen

• University degree in Life Sciences, Pharmacy, Chemistry or equivalent.
• Qualified to work as FvP per Swiss requirements (I-SMI.TI.17).
• Several years in pharma as (deputy-)FvP, senior in compliance or quality preferred.
• Strong knowledge of GMP, GDP, MDR and regulatory standards.

Aufgaben

• Ensure quality assurance and compliance as Technical Responsible Person for importation and wholesale distribution (AMBV).
• Perform batch release of medicinal products and medical devices for the Swiss market.
• Manage non-conformances, CAPAs and complaints to maintain quality.
• Maintain QMS and conduct internal audits and training activities.
• Communicate with Swiss health authorities and manage regulatory activities in Switzerland.

Kenntnisse

GMP knowledge

GDP knowledge

FvP Swiss requirements

Regulatory compliance

Problem solving

Interpersonal skills

German (C1)

English fluent

Ausbildung

University degree in Life Sciences / Pharmacy / Chemistry

Tools

QMS familiarity

Jobbeschreibung

Worklane GmbH in Zug, Switzerland, seeks an experienced Technical Responsible Person (FvP) / Senior QA for an 8‑month temporary assignment to lead the QMS, ensure GMP/GDP compliance, and perform batch release activities for the Swiss market.

You will collaborate with internal and external stakeholders, maintain registrations, support pharmacovigilance, and uphold high standards of quality and regulatory compliance. German C1 and fluent English are required.