QA Validation Specialist

Proclinical Staffing; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Proclinical Staffing is seeking a QA Validation Specialist to support a major expansion project in Switzerland. You will ensure GMP equipment, facilities, and systems are qualified, validated, and maintained in compliance with regulatory standards, working with operations, engineering, and regulatory bodies.

This role offers an opportunity to contribute to a critical phase of a large-scale manufacturing program, requiring strong QA expertise, proficiency in IQ/OQ/PQ, and a proactive,

Qualifikationen

• Experience in GMP-regulated pharmaceutical, biotech, or cell and gene therapy environments.
• Strong understanding of validation lifecycle (IQ/OQ/PQ).
• Proficiency in change control processes and documentation review.
• Familiarity with EU GMP and FDA regulations.
• Experience reviewing SOPs, validation protocols, reports, deviations, CAPAs, and change controls.

Aufgaben

• Oversee validation and qualification activities to keep GMP equipment, facilities, and systems in a validated state.
• Schedule and manage validation tasks for self and Level 1 team members as directed by Validation Manager.
• Conduct change control assessments for GMP equipment, facilities, and systems to ensure regulatory compliance.
• Develop validation protocols based on validation plans where applicable.
• Review and approve SOPs, validation protocols, reports, deviations, CAPAs, and change controls.
• Manage documentation and validation systems (DMS, LIMS, Kneat, Trackwise).
• Participate in audits and inspections to demonstrate EU GMP and FDA compliance.
• Provide technical expertise in IQ/OQ/PQ, autoclaves, clean utilities, shipping validation, temperature mapping, and controlled storage rooms.
• Support continuous improvement initiatives and other assigned duties.

Kenntnisse

GMP experience

Validation lifecycle (IQ/OQ/PQ)

Change control

Regulatory knowledge (EU GMP/FDA)

SOP/CAPA review

Documentation systems

English proficiency

Ausbildung

Science/Engineering background

Tools

DMS

LIMS

Kneat

Trackwise

Jobbeschreibung

Join a transformative GMP expansion project and make a lasting impact through validation, compliance, and quality excellence.

Proclinical is seeking a QA Validation Specialist to support a major expansion project in Switzerland. This role focuses on ensuring that GMP equipment, facilities, and systems are qualified, validated, and maintained in compliance with regulatory standards. You will work closely with operations, engineering teams, and regulatory bodies to uphold product quality and patient safety. This is an exciting opportunity to contribute to a critical phase of a large-scale manufacturing project in a collaborative and fast-paced environment.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Oversee validation and qualification activities to ensure GMP equipment, facilities, and systems remain in a validated state.
• Schedule and manage tasks for yourself and Level 1 team members as directed by the Validation Manager.
• Conduct change control assessments for GMP equipment, facilities, and systems to ensure regulatory compliance.
• Develop validation protocols based on validation plans, if applicable.
• Review and approve SOPs, validation protocols, reports, change controls, deviations, and CAPAs.
• Perform quality system activities, including managing documentation, validation systems, and tracking tools such as DMS, LIMS, Kneat, and Trackwise.
• Participate in audits and inspections to demonstrate compliance with EU GMP and FDA regulations.
• Provide technical expertise in areas such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), autoclaves, clean utilities, shipping validation, temperature mapping, and controlled storage rooms.
• Support continuous improvement initiatives and other assigned duties.

Key Skills and Requirements:

• Experience in GMP-regulated pharmaceutical, biotech, or cell and gene therapy environments.
• Strong understanding of validation lifecycle, including IQ, OQ, PQ, and maintaining systems in a validated state.
• Proficiency in change control processes and documentation review.
• Familiarity with EU GMP and FDA regulations.
• Experience reviewing and approving SOPs, validation protocols, reports, deviations, CAPAs, and change controls.
• Proficiency in English; German language skills are a strong plus.
• A background in science, engineering, biotechnology, chemistry, biology, pharmacy, or a related field is preferred but not essential if relevant experience is demonstrated.
• Ability to work autonomously, adapt quickly, and thrive in a fast-paced, multicultural, and collaborative environment.

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