QA Validation Specialist

Panda International; Oberwallis; Vor Ort; CHF 90.000 - 130.000; Vollzeit

Zusammenfassung

Panda International in Switzerland invites a QA Validation Specialist to join a small core team supporting an expansion of biologics manufacturing. You will ensure GMP equipment, facilities and systems are qualified, validated, and maintained, and you will participate in change control, documentation review, audits and regulatory inspections.

Ideal candidates have 2–6 years in Validation/Qualification, knowledge of OQ and PQ, and familiarity with EU GMP and FDA rules.

Qualifikationen

• 2–6 years of Validation / Qualification experience.
• Experience with EU GMP and FDA regulations.
• English proficiency required; German language skills are an advantage.
• Academic degree not mandatory if relevant industry experience is demonstrated.

Aufgaben

• Oversee QA of validation/qualification activities to maintain validated state.
• Plan and manage assigned validation tasks with the Validation Manager.
• Conduct change control assessments for GMP equipment, facilities, and systems.
• Review SOPs, protocols, reports, deviations, CAPAs and other quality records.
• Participate in audits, inspections, and continuous improvement initiatives.

Kenntnisse

CQV & Validation

QA oversight

Change control

Documentation review

Regulatory inspections

GMP compliance

Biologics manufacturing knowledge

OQ & PQ

Tools

DMS

LIMS

Validation mgmt systems

Jobbeschreibung

The QA Validation Specialist will report to the Head of QA Validation & Qualifications. The role will be part of a small core team consisting of permanent employees and this fixed-term contract position. The specialist will work closely with Operations, Engineering, external partners, and regulatory stakeholders.

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 ensure product quality and patient safety.

The role supports a major expansion project focused on increasing biologics manufacturing capabilities at a pharmaceutical manufacturing site in Switzerland. The project involves advanced automation, complex process control systems, and large-scale manufacturing operations.

Key Responsibilities

• Possess a strong understanding of Qualification (CQV) and Validation activities.
• Perform QA oversight of validation review and qualification activities to ensure GMP equipment, facilities, and systems remain in a validated/qualified state.
• Plan and manage assigned tasks, including activities delegated by the Validation Manager.
• Perform change control assessments for GMP equipment, facilities, and systems to ensure compliance with regulatory requirements.
• Demonstrate technical understanding of biologics manufacturing equipment, facilities, and validation procedures, including:
• Autoclaves
• Clean Utilities
• Shipping Validation
• Temperature Mapping of Controlled Storage Rooms and Equipment
• Develop validation protocols based on validation plans where applicable.
• Provide technical expertise during review and approval of:
• SOPs
• Protocols
• Reports
• Change controls
• Deviations
• Other quality records
• Perform Quality Systems activities using relevant systems, including:
• Document Management Systems (DMS)
• Laboratory Information Management Systems (LIMS)
• Validation and Qualification Management Systems
• Change Control, Deviation, and CAPA management systems
• Participate in audits, inspections, and continuous improvement initiatives to demonstrate compliance with European and US regulatory requirements.
• Experience within a GMP-regulated pharmaceutical, biotechnology, or cell & gene therapy environment.
• 2–6 years of Validation / Qualification experience.
• Strong understanding of:
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Maintaining systems in a validated state
• Change Control processes
• Documentation review
• Experience reviewing and approving:
• SOPs
• Validation protocols
• Validation reports
• Deviations
• CAPAs
• Change controls
• Familiarity with EU GMP and FDA regulations.
• English proficiency required; German language skills are a strong advantage.
• Academic degree is not mandatory if relevant industry experience is demonstrated. Ideally, candidates will have a background in:
• Biotechnology
• Biology
• Pharmacy
• Related scientific or technical disciplines

Personal Attributes

The ideal candidate will be able to quickly integrate into a critical project phase, work independently, and operate effectively in a fast-paced environment.

The role requires someone comfortable working within a multicultural and highly collaborative team environment, with strong ownership, adaptability, and a continuous improvement mindset.

This position offers the opportunity to contribute to a significant pharmaceutical manufacturing project while working with experienced professionals in a growing and dynamic environment.