Sterility Assurance Specialist till Lund

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Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
Summary
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.



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



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