Senior QA Specialist - Contamination Prevention & Control

The position will support the end-to-end contamination control strategies within our site manufacturing and support units and will be responsible for Premises and Utilities Qualification within Contamination Prevention & Control. The Senior QA Specialist ensures that qualification activities meet applicable regulatory requirements and internal quality standards and support the continued maintenance of facilities and utilities in a qualified and controlled state.

• 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.
• Participate in developing action plans to address deficiencies and ensure the 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.
• Provide microbiological expertise to support investigations, CAPAs, and change controls related to contamination prevention and control.
• Support regulatory inspections and customer audits as a Pharmaceutical Microbiology Subject Matter Expert.

• Bachelor’s degree in a relevant scientific discipline, preferably microbiology.
• Practical knowledge of performance qualification for manufacturing facilities, clean rooms, and clean utility systems is required.
• 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.

Practicalities

Location:

Visp, Switzerland Contract Type:
Contract Working Model:
Onsite