QA Validation Specialist

Actalent; Oberwallis; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

Actalent is seeking an experienced QA Validation Specialist to support qualification and validation activities within a GMP-regulated environment. The role focuses on maintaining equipment and systems in a validated state and supporting quality systems, change controls, and regulatory inspection readiness.

Responsibilities include IQ/OQ/PQ support, SOP and protocol reviews, and collaboration in audits and continuous improvement. Fluency in English is required; German is an advantage.

Qualifikationen

• 2–6 years of Validation/Qualification experience in a GMP pharma/biotech environment.
• Knowledge of IQ, OQ, PQ and validation lifecycle management.
• Experience with change controls and documentation review.
• Familiarity with EU GMP and FDA regulations.
• English proficiency; German is a plus.
• Science or technical degree or equivalent industry experience.

Aufgaben

• Provide QA oversight of qualification and validation activities for GMP equipment, facilities, and systems.
• Maintain validated state across lifecycle of equipment, facilities, and systems.
• Review change controls and related validation activities for regulatory compliance.
• Support IQ, OQ, and PQ qualification activities.
• Develop validation protocols from validation plans as needed.
• Review and approve SOPs, validation documents, deviations, CAPAs, and changes.
• Provide technical expertise related to validation and GMP compliance.
• Coordinate validation activities to support project timelines and business needs.
• Participate in audits, regulatory inspections, and continuous improvement initiatives.

Kenntnisse

QA oversight

Validation lifecycle

GMP compliance

Documentation review

Change controls

CAPA management

SOP review

Ausbildung

Science/Engineering degree

Jobbeschreibung

We are looking for an experienced QA Validation Specialist to support qualification and validation activities within a GMP-regulated environment. This role is responsible for ensuring equipment, facilities, and systems remain compliant, qualified, and maintained in a validated state while supporting quality systems, change controls, documentation review, and regulatory inspection readiness.

Key Responsibilities:

• Provide QA oversight of qualification and validation activities for GMP equipment, facilities, and systems.
• Ensure equipment, facilities, and systems are maintained in a validated and compliant state throughout their lifecycle.
• Review and assess change controls and associated validation activities to ensure regulatory compliance.
• Support and oversee qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop validation protocols from validation plans when required.
• Review and approve SOPs, validation protocols, validation reports, deviations, CAPAs, and change controls.
• Provide technical expertise related to validation, qualification, and GMP compliance activities.
• Support validation activities for manufacturing equipment, clean utilities, autoclaves, temperature mapping, controlled storage areas, and shipping validation.
• Utilize and maintain quality systems such as document management, validation management, deviation, CAPA, and change control systems.
• Participate in audits, regulatory inspections, and continuous improvement initiatives.
• Coordinate and prioritize assigned validation and qualification activities to support project timelines and business needs.

Requirements:

• 2–6 years of Validation/Qualification experience in a GMP-regulated pharmaceutical or biotech, environment.
• Strong knowledge of IQ, OQ, PQ, validation lifecycle management, and maintaining systems in a validated state.
• Experience with change controls, documentation review, and GMP compliance activities.
• Proven experience reviewing and approving SOPs, validation protocols, validation reports, deviations, CAPAs, and change controls.
• Familiarity with EU GMP and FDA regulations.
• Professional proficiency in English; German is a strong advantage.
• Scientific or technical degree preferred, or equivalent relevant industry experience.

Additional Information

• Duration: Contract until the end of the year