QA Validation Specialist (7080)

CTC Resourcing Solutions; Wallis; Vor Ort; CHF 140.000 - 210.000; Vollzeit

Zusammenfassung

The Life Science Career Network is seeking a QA Validation Specialist for a contract role in the Valais region of Switzerland. The position focuses on ensuring GMP equipment, facilities, and systems are qualified, validated, and maintained, with oversight of change control and regulatory inspections.

Ideal candidates have extensive CQV/validation experience in pharmaceutical or biopharmaceutical manufacturing, plus knowledge of IQ/OQ/PQ and related lifecycle processes, and are proficient in

Qualifikationen

• Relevant working/residency permit for Switzerland/EU
• 15–20 years of experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing
• Experience with IQ/OQ/PQ and Validation lifecycle

Aufgaben

• Oversee QA of Validation activities to maintain validated state of GMP equipment/facilities/systems
• Schedule tasks for self and for Level 1 per Validation Manager
• Perform change control assessments to ensure regulatory compliance
• Review and approve SOPs, validation protocols, reports, deviations and CAPAs
• Support audits and regulatory inspections in EU and FDA contexts
• Manage documentation within DMS, LIMS, Kneat and Trackwise systems

Kenntnisse

CQV

Validation

IQ/OQ/PQ

Change Control

Documentation Review

GMP

Audit readiness

Regulatory Inspections

English/German

Ausbildung

Science/Engineering degree

Tools

DMS

LIMS

Kneat

Trackwise

Jobbeschreibung

The Life Science Career Network

CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.

QA Validation Specialist

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a QA Validation Specialist for a contract position till end of 2026 (with option for extension) in Valais area, Switzerland.

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 guarantee product quality and patient safety.

Main Responsibilities:

• Must possess a full grasp of the duties of Qualifications (CQV) and Validation.
• Perform QA oversight of the Validation review and qualification activities to ensure GMP equipment, facility and/or systems are continuously maintained in a validated/qualified state.
• Schedule own tasks to be performed as well as tasks for Level 1 as determined by the Validation Manager.
• Perform change control assessments for GMP equipment, facility and/or systems and associated validation activities to ensure compliance with regulatory requirements.
• Demonstrate a thorough understanding of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment.
• Develop validation protocols from Validation plans (if applicable).
• Provide strong technical expertise when reviewing and approving SOPs, protocols, reports, change controls, deviations and other records.
• Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS), Validation and Qualification Management System (Kneat) and Trackwise system (Change Control, Deviations, CAPA, etc.).
• Perform other duties as assigned, like participate to Audits and inspections to demonstrate the compliance of the facility, equipment and systems with both European and US (FDA) regulations, and continuous improvement initiatives.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Quality Assurance / CQV professionals with 15-20 overall years of experience in GMP-regulated pharmaceutical and biopharmaceutical manufacturing sites
• The candidate should understand: IQ (Installation Qualification) / OQ (Operational Qualification) / PQ (Performance Qualification) / Validation lifecycle / Maintaining systems in a validated state / Change Control Experience / Documentation Review Experience
• Must have experience reviewing and approving: SOPs / Validation protocols / Validation reports / Deviations / CAPAs / Change controls
• Familiar with EU GMP and FDA regulations
• English proficiency and good German level
• Academic background not essential provided candidate has the right working experience , but ideally with a Science or Technical Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or related field.