QA Validation Specialist

Actalent; Schweiz; Vor Ort; CHF 80’000 - 100’000; Vollzeit

Zusammenfassung

A leading company seeks a QA Validation Specialist to support the validation of GMP-critical equipment and systems. You will ensure compliance with standards while collaborating with various teams. The ideal candidate has a strong background in validation and is ready to provide QA oversight.

Qualifikationen

• 2-6 years of experience in the pharmaceutical industry, preferably in a GMP environment.
• Strong understanding of validation principles and regulatory requirements.
• Ability to work independently and mentor less experienced team members.

Aufgaben

• Provide QA oversight for validation and qualification activities.
• Conduct change control assessments for GMP systems.
• Develop validation protocols based on validation plans.

Kenntnisse

Documentation skills

Communication skills

Organizational skills

Ausbildung

Bachelor’s degree in a scientific or technical discipline

Tools

Document Management System (DMS)

Laboratory Information Management System (LIMS)

Kneat

TrackWise

Jobbeschreibung

We are seeking aQA Validation Specialistto join our client's team and support the validation of GMP-critical equipment, facilities, and systems. This role ensures compliance with user requirements, process parameters, and global regulatory standards. As a key member of the Quality Assurance team, you will collaborate with operations, clients, and regulatory bodies to provide scientifically sound, documented evidence that their systems and processes consistently deliver a compliant and high-quality manufacturing environment.

Responsibilities:

• Provide QA oversight for validation and qualification activities to ensure GMP systems remain in a validated state.
• Independently schedule and manage validation tasks, including those assigned to junior team members.
• Conduct change control assessments for GMP systems and related validation activities to ensure regulatory compliance.
• Apply in-depth knowledge of Cell and Gene Therapy manufacturing equipment and validation procedures, including: Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation and Temperature Mapping for Controlled Storage Rooms and Equipment
• Develop validation protocols based on validation plans.
• Review and approve technical documentation such as SOPs, protocols, reports, change controls, deviations, and other quality records.
• Support Quality Systems activities, including: Document Management System (DMS), Laboratory Information Management System (LIMS), Kneat and TrackWise.

Must-Haves:

• Education: Bachelor’s degree in a scientific or technical discipline.
• Experience: 2–6 years in the pharmaceutical industry, preferably in a GMP environment.
• Strong understanding of validation principles and regulatory requirements.
• Ability to work independently and mentor less experienced team members.
• Excellent documentation, communication, and organizational skills.

Location:l Visp, Switzerland

Duration: 12 months contract

Start date: ASAP

If you feel confident about this opportunity, we encourage you to apply, or to reach out to me via email at [e-mail].

Job Title: QA Validation Specialist

Location: Visp, Switzerland

Job Type: Contract

Aerotek, an Allegis Group company. Allegis Group AG, Aeschengraben 20, CH-4051 Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield