QA Validation Specialist (Fixed-Term Contract)

Source Technology Limited; Schweiz; Vor Ort; EUR 96.525 - 128.700; Vollzeit

Zusammenfassung

Source Technology Limited seeks a QA Validation Specialist to support a major biologics expansion project in canton Valais. The role ensures GMP equipment, facilities, and systems stay qualified, validated, and inspection-ready throughout the lifecycle.

The candidate will engage in validation, qualification, change control, and GMP documentation review in a fast-paced project environment, delivering immediate value and cross-functional collaboration.

Qualifikationen

• 2–6 years' experience in Validation, Qualification, CQV or QA Validation within a GMP-regulated pharma/biotech environment.
• Strong knowledge of IQ, OQ, PQ, validation lifecycle management, and maintaining a validated state.
• Experience reviewing and approving GMP documentation (SOPs, validation protocols and reports, deviations, CAPAs, change controls).
• Working knowledge of EU GMP and FDA regulations.
• Fluent English; German is an advantage.
• Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy or related discipline preferred.

Aufgaben

• Provide QA oversight of equipment, facility, and utility qualification and validation activities.
• Review and approve validation protocols, reports, SOPs, deviations, CAPAs, and change controls.
• Assess impact of changes to GMP systems and ensure appropriate validation activities are completed.
• Ensure systems remain in a validated state and comply with EU GMP and FDA requirements.
• Develop validation protocols from approved validation plans when required.
• Use and maintain quality systems including TrackWise, Kneat, DMS, and LIMS.
• Support internal audits, regulatory inspections, and continuous improvement initiatives.

Kenntnisse

Validation management

IQ/OQ/PQ

GMP knowledge

Regulatory compliance

Ausbildung

Engineering degree

Biotechnology/Pharmacy background

Tools

TrackWise

Kneat

DMS

LIMS

Jobbeschreibung

QA Validation Specialist (Fixed-Term Contract)

We are seeking an experienced QA Validation Specialist to support a major biologics manufacturing expansion project in canton Valais. You will play a key role in ensuring GMP equipment, facilities, and systems remain qualified, validated, and inspection-ready throughout the project lifecycle.

This is a hands‑on role requiring strong expertise in validation, qualification, change control, and GMP documentation review. The successful candidate will be able to quickly integrate into a fast‑paced project environment and provide immediate value.

Key Responsibilities

• Provide QA oversight of equipment, facility, and utility qualification and validation activities.
• Review and approve validation protocols, reports, SOPs, deviations, CAPAs, and change controls.
• Assess the impact of changes to GMP systems and ensure appropriate validation activities are completed.
• Ensure systems remain in a validated state and comply with EU GMP and FDA requirements.
• Support qualification activities including:
  • IQ, OQ, and PQ
  • Autoclaves
  • Clean Utilities
  • Shipping Validation
  • Temperature Mapping
• Develop validation protocols from approved validation plans when required.
• Use and maintain quality systems including TrackWise, Kneat, DMS, and LIMS.
• Support internal audits, regulatory inspections, and continuous improvement initiatives.

Requirements

• 2-6 years' experience in Validation, Qualification, CQV, or QA Validation within a GMP-regulated pharmaceutical, biotech, biologics, or cell & gene therapy environment.
• Strong knowledge of IQ, OQ, PQ, validation lifecycle management, and maintaining a validated state.
• Experience reviewing and approving GMP documentation, including:
  • SOPs
  • Validation protocols and reports
  • Deviations
  • CAPAs
  • Change Controls
• Working knowledge of EU GMP and FDA regulations.
• Fluent English; German is an advantage.
• Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or related discipline preferred, though equivalent industry experience will also be considered.

Candidate Profile

• Able to hit the ground running in a critical project phase.
• Comfortable working independently and managing priorities.
• Strong attention to detail and quality mindset.
• Effective communicator with the ability to work across Engineering, Operations, Quality, and external stakeholders.
• Thrives in a collaborative and multicultural environment.