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Are you passionate about quality, scientific rigor, and innovation in the life sciences? Join a dynamic team where your expertise will directly contribute to ensuring the compliance and performance of critical GMP equipment, facilities, and systems.
As a QA Validation Specialist, you play a key role in maintaining a compliant, safe, and high-performing manufacturing environment. You will ensure that all equipment, facilities, and systems remain in a validated state, aligned with user requirements, process parameters, and global regulatory standards.
- Provide QA oversight for validation and qualification activities to ensure GMP compliance.
- Conduct change control assessments and ensure alignment with regulatory expectations.
- Develop and review validation protocols (IQ, autoclaves, clean utilities, shipping validation, temperature mapping, etc.).
- Collaborate closely with Operations, Quality Assurance, clients, and regulatory bodies.
- Offer technical expertise in reviewing and approving SOPs, protocols, reports, deviations, CAPAs, and change controls.
- Manage quality systems such as DMS, LIMS, Kneat, and Trackwise.
- Mentor junior team members and coordinate tasks in collaboration with the Validation Manager.
- Bachelor’s degree in a scientific or technical field.
- 2–6 years of experience in the pharmaceutical industry.
- Solid understanding of cell and gene therapy manufacturing equipment and validation processes is a plus.
- Strong analytical mindset, attention to detail, and a collaborative spirit.
Seniority level
Seniority level
Entry level
Employment type
Job function
Job function
Quality AssuranceIndustries
Pharmaceutical Manufacturing
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