Sterility Assurance SpecialistReq # JR - 026027 Location Lund, Skåne County, Sweden Job Category Quality Control Date posted 09/10/2020
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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 Baxter 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.
- 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
- Critical thinking and decision making
- Collaboration and teamwork
- Dealing with ambiguity
- Good management and communication skills
- Customer and patient focus
What we can offer
- A challenging opportunity for you and also a chance to work in a diverse and experienced team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
- Independent position with an opportunity to build your own strategy and make a real impact
- A chance to further build your professional experience in the area of health care
- Internal training tailored to business needs and career goals
- Stability of employment in a recognizable and established company
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.