Due to the substantial increase in our business, we are currently looking for a Quality Assurance Specialist, to join our team of consultants.

• 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 cGMP 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