Senior QA Specialist - Maternity Cover - 7122

CTC Resourcing Solutions; Oberwallis; On-site; CHF 90,000 - 120,000; Full time

Job summary

CTC Resourcing Solutions supports a global market leader in Visp, Switzerland, by recruiting a Senior QA Specialist for a 7-month maternity cover. The role centers on end-to-end contamination control, facilities and utilities qualification, and maintaining compliant quality systems in manufacturing environments.

The candidate brings GMP expertise, microbiology knowledge, and strong regulatory proficiency (FDA/EMA), with excellent documentation skills and the ability to lead investigations and

Qualifications

• Bachelor’s degree in a relevant scientific discipline, preferably microbiology.
• Knowledge of performance qualification for manufacturing facilities, cleanrooms, and clean utility systems.
• GMP experience in biologics with QA or QC microbiology background.
• Familiarity with FDA and EMA requirements.
• Strong written and verbal communication and documentation skills.

Responsibilities

• Provide QA 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.
• Analyse 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.

Skills

GMP experience

Quality Assurance

Quality Control Microbiology

Environmental monitoring

Contamination control

Manufacturing facilities qualification

Regulatory knowledge (FDA/EMA)

Documentation

Team collaboration

Problem-solving

Education

Bachelor’s degree in microbiology

Job description

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

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 QA Specialist - Maternity cover, based in Visp, Switzerland for a 7 months contract, with the possibility of extension.

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.

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. Participate in developing action plans to address deficiencies and ensure the appropriate microbiological quality of site facilities, utilities, processes, and products.
• Analyse 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.

Required Qualifications

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• Bachelor’s degree in a relevant scientific discipline, preferably microbiology.
• Practical knowledge of performance qualification for manufacturing facilities, cleanrooms, 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.