QA Engineering Specialist (Life Sciences)

TL;DR

QA Engineering Specialist (Life Sciences): Ensuring GMP compliance across production, analytical, and infrastructure systems with an accent on lifecycle management and validation projects. Focus on creating GMP-relevant documentation, supporting regulatory inspections, and coordinating technical quality-related issues.

Location: Onsite in Basel, Switzerland

Company

hirify.global is a leading international engineering, architecture, and project management firm specializing in the delivery of complex capital projects for life sciences, medtech, and advanced manufacturing sectors.

What you will do

• Manage the lifecycle of GMP-relevant facilities, including requalification, maintenance, and change control.
• Execute and provide expert QA evaluation for qualification and validation projects involving equipment and infrastructure.
• Draft, review, and approve critical GMP documents, including URS, SOPs, and qualification packages.
• Advise stakeholders on technical and quality-related issues and report on compliance status.
• Coordinate and support regulatory authority inspections and customer audits.
• Lead small-scale quality engineering projects and enhance cross-functional quality processes.

Requirements

• Bachelor's degree in Chemistry, Pharmacy, Process Engineering, or a comparable field.
• 2–3 years of professional experience in a GMP-regulated environment, specifically in qualification or technical QA.
• Strong knowledge of Swiss and EU GMP regulations.
• Fluent German (C1) and good English (B2), both spoken and written.
• Proficiency in MS Office and experience with ERP/MES/QM systems.
• Must be based in or able to work onsite in Basel, Switzerland.

Culture & Benefits

• Work in an employee-owned company with a culture of inclusion and mutual respect.
• Commitment to corporate responsibility and sustainability as part of the 2029 business strategy.
• Diverse and inclusive workplace valuing different talents and ideas.
• Fair and accessible hiring process with accommodations for candidates with disabilities.