Manager - QA Validation - 7078

CTC Resourcing Solutions; Wallis; Vor Ort; CHF 120.000 - 150.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions is seeking a QA Validation Manager for a contract position in the Valais area of Switzerland. The role focuses on ensuring GMP processes are validated and maintained, with collaboration across MSAT, Manufacturing, and client teams to deliver scientifically sound validation evidence.

Key responsibilities include managing CPV, process validation, cleaning validation, and related change controls. Fluency in English is required; German is a plus.

Qualifikationen

• Bachelor's degree in Science, Biotechnology, or related field.
• 5-7 years in pharmaceutical GMP environment.
• Strong knowledge of process validation and cleaning validation.
• Experience with change controls, deviation management, and non-conformity investigations.
• Fluent in English; German is a plus.

Aufgaben

• Validate and maintain critical GMP processes per product requirements and regulatory guidelines.
• Collaborate with MSAT, Manufacturing, and clients to provide evidence-based validation.
• Oversee CPV and process validation activities for biotechnological manufacturing.
• Review validation documentation (Process, Cleaning, CSV) and SOPs.
• Support audits and inspections to demonstrate compliance with EU/US FDA regulations.

Kenntnisse

GMP compliance

Process validation

Cleaning validation

Deviation management

Change controls

Documentation review

SOP review

QA liaison

Risk assessment

Ausbildung

Bachelor's degree

Science/Biotech

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.

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 Manager for a contract position till end of 2026 (with option for extension) in Valais area, Switzerland.

The QA Validation Manager is responsible for ensuring all critical GMP processes are validated and maintained in compliance with product requirements, process parameters, and global regulatory guidelines. The role works closely with MSAT, Manufacturing, and clients to provide scientifically sound, documented evidence that processes will perform as required, assuring sustainable product quality. The position serves as a key QA point of contact for validation projects, product transfers, and validation strategy, while supporting compliance throughout the product lifecycle.

Main Responsibilities:

• Ensure critical GMP processes are validated and maintained in compliance with product requirements, process parameters, and global regulatory guidelines.
• Collaborate closely with MSAT, Manufacturing, and clients to ensure processes are supported by scientifically sound and documented evidence.
• Maintain oversight of validation activities for biotechnological manufacturing processes in a low bioburden environment.
• Support validation of manual and automated cleaning and sanitization processes.
• Oversee qualification requirements of related equipment and systems.
• Manage continuous process verification (CPV) and process validation activities.
• Act as a key QA point of contact for product transfer activities and related validation strategies.
• Prioritize and manage workload in alignment with line manager requirements and site goals.
• Perform change control and deviation impact assessments.
• Support investigations of non-conformities.
• Demonstrate understanding of cell and gene manufacturing processes, equipment, product control strategies, and low bioburden environmental assurance.
• Provide technical expertise in the review and approval of SOPs, protocols, reports, change controls, deviations, and other GMP records for QA closure.
• Participate in audits and inspections to demonstrate compliance with European and U.S. FDA regulations.
• Serve as the subject matter expert (SME) for SOPs related to Process Validation and Cleaning Validation.
• Review and approve validation documentation, including Process Validation, Cleaning Validation, and Computer System Validation (CSV) documentation.
• Participate in risk assessments.
• Support the Data Integrity Program.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Bachelor's degree in Science, Biotechnology, or a related field.
• 5-7 years of experience in the pharmaceutical industry within a GMP-regulated environment.
• Strong knowledge of process validation, cleaning validation, and equipment/system qualification.
• Experience with change controls, deviation management, and non-conformity investigations.
• Understanding of cell and gene manufacturing processes and low bioburden environments.
• Proficiency in English; German is a plus.