Senior Qualification Specialist (7053 – KFR)

CTC Resourcing Solutions; Wallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

CTC is seeking a Senior Qualification Specialist for a contract position till end of March 2027 in the Valais region, Switzerland. Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems, and support ongoing validation post-implementation.

Candidate will coordinate between internal teams and external service providers, manage deviations and CAPAs, and prepare qualification documents for audits and inspections, demonstrating high GMP

Qualifikationen

• Experience in GMP, commissioning, qualification and validation.
• Strong documentation and regulatory knowledge.
• German and/or English language proficiency.

Aufgaben

• Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems.
• Supervise deviations, changes (GEP and GMP) and CAPAs.
• Coordinate internal teams and external service providers for project execution.
• Present qualification documents during audits and inspections.

Kenntnisse

GMP experience

Documentation

Regulatory knowledge

Audits

Project coordination

Ausbildung

HF/FH degree or university

Tools

COMOS

DMS

Kneat

TrackWise

SAP

Jobbeschreibung

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.

Senior Qualifying 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 Senior Qualification Specialist for a contract position till end of March 2027 (with option for extension) in Valais area, Switzerland.

Main Responsibilities:

• Develop and maintain commissioning and qualification documents for new plants, including PQs for critical systems and ongoing SLC support post-implementation.
• Supervise and resolve deviations, manage changes (GEP and GMP), and implement CAPAs effectively.
• Coordinate efforts between internal teams and external service providers and suppliers to ensure seamless project execution.
• Present qualification documents during audits and inspections, showcasing the outstanding standards maintained.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Graduate from a technical school (HF) / university of applied sciences (FH) or hold a university degree.
• Proven experience in a regulated GMP environment, specifically in commissioning, qualification, and validation of systems like refrigerators, freezers, clean media, and process engineering equipment.
• Strong proficiency in MS Office; familiarity with COMOS, DMS, Kneat, TrackWise, and SAP is advantageous.
• Proficient in both written and spoken German and/or English.
• Demonstrate independent, flexible work habits, with excellent communication skills and a structured, focused approach to tasks.
• Open to new ideas, agile in thinking, and proactive in problem-solving.