QA Validation Specialist

EFOR; Oberwallis; Vor Ort; CHF 90.000 - 135.000; Vollzeit

Zusammenfassung

EFOR Group in Visp, Switzerland, seeks a QA Validation Specialist to ensure GMP equipment, facilities and systems are qualified, validated and maintained for product quality and patient safety. The role includes CQV activities, change control, documentation review and support for audits and regulatory inspections, as part of a major expansion of mammalian cell culture capabilities.

Based in Visp on-site, you will collaborate with Operations, Engineering and regulatory bodies, applying EU GMP and

Qualifikationen

• GMP-regulated pharma/biotech environment experience required.
• 2–6 years Validation / Qualification experience.
• Understanding CQV stages IQ -> PQ.
• Validation lifecycle and maintaining validated state knowledge.
• Experience with Change Control and Documentation Review.
• Familiar with EU GMP and FDA regulations.

Aufgaben

• Oversee Validation reviews to ensure GMP equipment, facility and/or systems are qualified.
• Schedule tasks per Validation Manager and Level 1 assignments.
• Perform change control assessments for GMP equipment and systems.
• Demonstrate understanding of IQ, autoclaves, clean utilities, storage and temperature mapping.
• Develop validation protocols from Validation plans.
• Review and approve SOPs, protocols, reports, deviations and CAPAs.
• Manage QA systems: DMS, LIMS, Kneat, Trackwise.
• Support audits and inspections to demonstrate regulatory compliance (EU/FDA).

Kenntnisse

GMP/QA experience

CQV knowledge (IQ/PQ)

Validation lifecycle understanding

Change control

Documentation review

Audits & regulatory inspections

Regulatory knowledge (EU GMP, FDA)

Quality systems familiarity

Tools

Kneat

TrackWise

LIMS

DMS

Jobbeschreibung

In 13 years, the EFOR Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions.

Our ambition is to build a global leading position of our market in 2028.

Today, we are an innovative organization working with passionate specialists and committed consultants according to our three values: Commitment, Excellence and Sharing.

In Switzerland, we work with 300 experts who support our customers on their various projects in the French- and German-speaking parts. We help our customers to diversify and to grow through the work of our consultants and the technical expertise of our Solution & Project Delivery Department.

To strengthen our team in the Visp, we are looking for a QA Validation Specialist

The Role:

The specialist works closely with Operations, Engineering, our clientele, and regulatory bodies .

The QA Validation Specialist is responsible for ensuring that GMP equipment, facilities, and systems are properly qualified, validated, maintained in a compliant state, and supported through change control, documentation review, audits, and regulatory inspections to guarantee product quality and patient safety. This project entails a major expansion of mammalian cell culture and biologics manufacturing capabilities located at the company's site in Visp, Switzerland.

Your Responsibilities:

• Must possess a full grasp of the duties of Qualifications (CQV) and Validation.
• Perform QA oversight of the Validation review and qualification activities to ensure GMP equipment, facility and/or systems are continuously maintained in a validated/qualified state.
• Schedule own tasks to be performed as well as tasks for Level 1 as determined by the Validation Manager.
• Perform change control assessments for GMP equipment, facility and/or systems and associated validation activities to ensure compliance with regulatory requirements.
• Demonstrate a thorough understanding of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from Validation plans (if applicable).
• Provide strong technical expertise when reviewing and approving SOPs, protocols, reports, change controls, deviations and other records.
• Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS), Validation and Qualification Management System (Kneat) and Trackwise system (Change Control, Deviations, CAPA, etc.).
• Perform other duties as assigned, like participate to Audits and inspections to demonstrate the compliance of the facility, equipment and systems with both European and US (FDA) regulations, and continuous improvement initiatives.

Your Qualifications & Experience:

• GMP-regulated pharmaceutical, biotech, or cell & gene therapy environment.
• 2–6 years Validation / Qualification Experience
• The candidate should understand concepts and steps involved in CQV stages IQ -> PQ
• Validation lifecycle
• Maintaining systems in a validated state.
• Change Control Experience
• Documentation Review Experience
• Must have experience reviewing and approving; SOPs, Validation protocols, Validation reports, Deviations, CAPAs, Change controls
• Familiar with EU GMP and FDA regulations

This is an on-site role.

EFOR Group’s legal entity, KALIPSIA AG is based at Holbeinstr. 50, 4051 Basel, is recruiting and managing client relationships. The recruitment is for assignments and projects carried out for our clients, as well as for company mandates.

Only applicants with Swiss or EU/EFTA citizenship or candidates with an existing and valid residence and work permit in Switzerland will be considered.

Do you want to join a dynamic and ambitious company? EFOR is made for you.