Spezialist für QA Coompliance

Gi Group; Oberwallis; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Gi Group is seeking an experienced QA Validation Specialist for a global leader in biopharmaceutical manufacturing in Switzerland. You will oversee qualification and validation activities to keep GMP equipment, facilities and systems in a validated state.

Responsibilities include reviewing SOPs, validation protocols/reports, deviations and CAPAs; supporting validation across GMP equipment, clean utilities, autoclaves, storage, shipping validation, and temperature mapping.

Qualifikationen

• Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy or related field; equivalent experience considered.
• Experience in GMP-regulated pharma/biotech or Cell & Gene Therapy environments.
• 2-6 years in Validation and Qualification (CQV).
• Strong IQ/OQ/PQ and validation lifecycle understanding.
• Experience reviewing SOPs, validation protocols, deviations, CAPAs and change controls.
• Familiarity with EU GMP and FDA regulations.
• Fluent in English; German is a strong advantage.

Aufgaben

• Perform QA oversight of qualification and validation activities to ensure GMP equipment, facilities, and systems remain validated and compliant.
• Assess and review change controls, deviations, CAPAs, and validation-related activities.
• Provide QA review and approval of SOPs, validation protocols, validation reports, and related quality documentation.
• Support qualification and validation activities related to GMP equipment, facilities, clean utilities, autoclaves, storage areas, shipping validation, and temperature mapping.
• Develop validation protocols from validation plans and provide technical expertise throughout the lifecycle.
• Utilize and maintain DMS, LIMS, Kneat, and TrackWise for validation/quality management.
• Participate in audits, inspections, and continuous improvement to meet EU GMP and FDA requirements.

Kenntnisse

CQV

GMP knowledge

Validation lifecycle

Change control

SOP approval

QA documentation

Ausbildung

Engineering / Biotechnology / Chemistry / Biology / Pharmacy degree

Tools

DMS

LIMS

Kneat

TrackWise

Jobbeschreibung

For our client, a global leader in biopharmaceutical manufacturing, we are seeking an experienced

QA Validation Specialist (m/w/d)

General Information

• Start Date: 03.08.2026
• Duration: until 31.12.2026

Tasks & Responsibilities

• Perform QA oversight of qualification and validation activities to ensure GMP equipment, facilities, and systems remain in a validated and compliant state.
• Assess and review change controls, deviations, CAPAs, and validation-related activities to ensure compliance with regulatory requirements.
• Provide QA review and approval of SOPs, validation protocols, validation reports, and associated quality documentation.
• Support qualification and validation activities related to GMP equipment, facilities, clean utilities, autoclaves, controlled storage areas, shipping validation, and temperature mapping.
• Develop validation protocols based on validation plans and provide technical expertise throughout the validation lifecycle.
• Utilize and maintain quality systems including DMS, LIMS, Kneat, and TrackWise for validation and quality management activities.
• Participate in audits, inspections, and continuous improvement initiatives to ensure compliance with EU GMP and FDA regulatory requirements.

Your Profile

• Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or a related scientific/technical discipline is preferred; equivalent experience will also be considered.
• Experience within a GMP-regulated pharmaceutical, biotechnology, or Cell & Gene Therapy environment.
• 2-6 years of experience in Validation and Qualification (CQV).
• Strong understanding of IQ, OQ, PQ, validation lifecycle principles, and maintaining systems in a validated state.
• Experience reviewing and approving SOPs, validation protocols, validation reports, deviations, CAPAs, and change controls.
• Practical experience with change control processes and validation documentation review.
• Familiarity with EU GMP and FDA regulations.
• Fluent in English; German is a strong advantage.