Sterility Assurance Specialist

Modis Life Science is now looking for a microbiologist to a temporary assignment at a pharmaceutical company in Lund. The assignment will run for approximately 1-1,5 year. Send your application to us if you find the role interesting. Deadline January 5th. 

About the assignment.

Modis is now looking for a Sterility Assurance Specialist. The Sterility Assurance specialist will provide technical expertise and support to the DVM Process for all sterility assurance aspects. He/she will act as a valuable and effective source of information and advice on sterility assurance and will positively contribute to the DVM Lund Quality Management Team. He/she will be responsible for ensuring that the DVM Lund maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.

Essential Duties and Responsibilities

• Responsible for ensuring effective sterility assurance and environmental monitoring programmes are deployed in the DVM facility in compliance with current GMP and the global strategy.
• Supporting the Global compounding organization on standardization of sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
• Participation in continuous improvement projects and providing the expert guidance and assessment for the questions related with Sterility insurance, including risk reduction initiatives in line with company strategy
• Support and lead problem solving investigations for product and process deviations or customer complaints
• Provide coaching and mentoring to other functions in problem solving with respect to Sterility Assurance
• Participate in the DVM Lund complaints investigation, Nonconformance and quality incidents investigation, act as technical approver.
• Provide technical support in interpretation of Microbial Identification and Environmental Monitoring data and for the trending of EM and Microbiological data including setting of appropriate Alert limits
• Responsible for the Tracking and Reporting or Quality Metrics for internal and external use.
• Carry out validation and experimental design in association with EMEA Sterility Assurance Manager
• Qualification, Auditing and monitoring the service Levels of external Lab, providing the proper oversight on technical aspects
• Support the development of the quality documentation including local SOP´s, approval of documents related with Sterility Assurance as Technical Approver.
• Providing Microbiological training and Aseptic Operator Training for operational and quality staff including periodic reassessment.

Qualifications

• Degree in Microbiology, although others may be considered with relevant experience
• Required 2 years´ experience in implementing environmental control programs, OOL investigation and correction and support to aseptic or similar clean room environments
• Preferred 3 to 5 years experience of microbiology experience in an aseptic facility
• Must have strong operational experience preferably in an aseptic manufacturing background, sterile manufacture or similar Medical Device or Biopharmaceutical background
• Experience of aseptic technique
• Have excellent interpersonal skills and strong influencer
• Be a passionate advocate of quality as a discipline and continuous improvement
• Have experience in the use of quality improvement and problem solving skills (ie FMEA, DMAIC, Process Mapping etc) and the interpretation of data, experience of Lean manufacturing
• Have experience of critical equipment and process Change Control
• Have experience of validation of microbiological methods or sanitization processes
• Able to work autonomously and take the initiative

Demonstrate

• Critical thinking and decision making
• Collaboration and teamwork
• Dealing with ambiguity
• Good management and communication skills
• Customer and patient focus