Senior QA Specialist – Maternity Cover (7122)

Senior QA Specialist – Maternity Cover

Join a global market leader in the production and process support of active pharmaceutical ingredients across the chemical and biotechnology sectors. This 7-month contract position, based in Visp, Switzerland, offers the potential for extension and provides the opportunity to support end-to-end contamination control strategies within site manufacturing and support units.

In this role, you will be responsible for Premises and Utilities Qualification within Contamination Prevention & Control. You will ensure that qualification activities meet applicable regulatory requirements and internal quality standards, supporting the continued maintenance of facilities and utilities in a qualified and controlled state.

Main Responsibilities

• Provide Quality oversight for the qualification, including environmental monitoring performance qualification, of manufacturing facilities and the performance qualification of clean utility systems.
• Ensure that facilities and quality systems remain compliant with internal requirements and applicable regulations, participating in developing action plans to address deficiencies and ensure appropriate microbiological quality of site facilities, utilities, processes, and products.
• Analyze and interpret environmental monitoring outputs, identify trends, and implement appropriate corrective actions.
• Collaborate with cross-functional teams to ensure that contamination prevention and control requirements are met for new product introductions, facility adaptations, and process changes.
• Lead and guide investigations into monitoring excursions, contamination incidents, and deviations from contamination control procedures, providing microbiological expertise to support investigations, CAPAs, and change controls.
• Support regulatory inspections and customer audits as a Pharmaceutical Microbiology Subject Matter Expert.

Required Qualifications

• Swiss or EU citizen with the right to work in Switzerland.
• Bachelor’s degree in a relevant scientific discipline, preferably microbiology.
• Practical knowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility systems.
• Substantial GMP experience in the biologics industry, with direct Quality Assurance or directly relevant Quality Control Microbiology experience.
• Strong knowledge of contamination control principles, practices, and applicable regulations, including FDA and EMA requirements.
• Working knowledge of microbiological testing methods, media challenges, environmental monitoring, cleanroom qualification and management, and microbiological control strategies.
• Excellent written and verbal communication skills, including accurate and clear documentation skills.
• Ability to work effectively in a fast-paced environment, both independently and as part of a team, with a strong work ethic.
• Strong problem-solving mindset and sound decision-making skills.
• Strong sense of ownership and the ability to prioritize activities based on business needs.