Job description:

• Supports creation and implementation of the aseptic operator training program for the site
• Creation and update of procedures and risk assessments
• Ensures adherence to global procedures and standards
• Creation of SOPs in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
• Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behavior, Transitional spaces, gowning procedures)
• Supports Annex 1 Gap mitigation and remediation in collaboration with the manufacturing department (e.g. creation of work instructions, risk assessments, process design)

Your profile:

• Minimum 4 years of experience in the industry
• Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and c GMP compliance.
• Experience in the pharmaceutical manufacturing industry, specifically aseptic processing
• Demonstrated experience in quality assurance and regulatory compliance with EU GMP Annex¨
• Fluent in both English and German

Qui sommes nous ?
Since 2005, the largest laboratories have renewed their trust in us. Specialized in pharmaceuticals, biotechnology and medical devices, we support our clients from R&D to the market launch of their products.

Human-scale company, belonging to the Vulcain Engineering Group, we are committed to supporting and advancing our employees who are recognized for their technical and scientific expertise. Through our regional subsidiaries, we guarantee each one a geographical stability, without mobility clause on the main basins of activities in France, Belgium, Switzerland, Denmark and Canada.

At Consultys, we prove that it is possible to combine Human and Performance.

Much more than concepts, our 3 values "Respect, Recognition and Transparency" guide us and are the foundation of our history, the heart of our group’s success.

Most of Consultys:

• Stable, senior teams that accompany you in taking charge of your position

• Tailor-made training tailored to your career prospects

• The guarantee of working close to you, without geographical mobility