QA Validation Specialist

Gi Group; Visp; Vor Ort; CHF 70’000 - 90’000; Vollzeit

Zusammenfassung

A leading company in pharmaceutical manufacturing seeks a QA Validation Specialist to ensure compliance and performance of critical GMP equipment in a dynamic environment. This role involves oversight of validation activities, collaboration with teams, and mentoring junior members. Ideal candidates will have a scientific degree and relevant industry experience.

Qualifikationen

• 2–6 years of experience in the pharmaceutical industry is preferred.
• Solid understanding of cell and gene therapy manufacturing equipment is a plus.

Aufgaben

• Provide QA oversight for validation and qualification activities.
• Conduct change control assessments and ensure regulatory alignment.
• Develop and review validation protocols.

Kenntnisse

Attention to detail

Analytical mindset

Collaboration

Ausbildung

Bachelor’s degree in a scientific or technical field

Tools

DMS

LIMS

Kneat

Trackwise

Jobbeschreibung

Direct message the job poster from Gi Group

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

• Employment type

  Temporary

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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