CTC – Your Recruitment Partner in Life Sciences
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.
Job Opportunity: Senior QA Specialist – Maternity Cover
Our client, a global market leader in the production and process support of active pharmaceutical ingredients in both the chemical and biotechnology sectors, is seeking a Senior QA Specialist for a maternity cover position based in Visp, Switzerland. This is a 7-month contract, with the possibility of extension.
Position Overview
The Senior QA Specialist will support the end-to-end contamination control strategies within our site manufacturing and support units. This role will focus on Premises and Utilities Qualification within Contamination Prevention & Control, ensuring that qualification activities comply with applicable regulatory requirements and internal quality standards. Additionally, this position will support the ongoing maintenance of facilities and utilities in a qualified and controlled state.
Main Responsibilities
- Provide Quality oversight for the qualification of manufacturing facilities, including environmental monitoring performance qualification and clean utility systems.
- Ensure that facilities and quality systems comply with internal requirements and applicable regulations. Participate in developing action plans to address deficiencies and maintain 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 meet contamination prevention and control requirements during 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.
- 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 involvement in Quality Assurance or relevant Quality Control Microbiology.
- 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 microbiological control strategies.
- Excellent written and verbal communication skills, with a focus on accurate and clear documentation.
- Ability to function effectively in a fast-paced environment, both independently and as part of a team.
- Strong problem-solving mindset and sound decision-making skills.
- A strong sense of ownership, with the ability to prioritize activities based on business needs.
Application Process
If you are interested in learning more about this opportunity, apply online using the form below. Please note that only applications matching the job profile will be considered.
Work location, Switzerland