Sterility Assurance Specialist
Modis Sweden AB / Laborantjobb / Lund
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hela Sverige 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
Varaktighet, arbetstid
Heltid Visstid
Publiceringsdatum2020-12-16ErsättningFast lön
Så ansöker duSista dag att ansöka är 2021-01-15
Klicka på denna länk för att göra din ansökanFöretagModis Sweden AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Modis Sweden AB (org.nr 556694-0044),
http://www.modis.se/ Jobbnummer 5491079
Observera att sista ansökningsdag har passerat.