Microbiologist
Poolia Sverige AB / Kemiingenjörsjobb / Lund
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hela Sverige Do you want to contribute to a top quallity medical research? We are searching for a Microbiologist that wants to work for a global meditech company that touches the lives of millions of people around the world every day.
Publiceringsdatum2021-09-21Om tjänstenThe Microbiologist will work closely with the Sterility Assurance function, reporting to the Head of Quality. The role will work with QA and Operations to ensure an appropriate and robust Environmental Monitoring programme is adhered to as part of the overall Microbial Control Strategy, under the supervision of the Sterility Assurance Specialist. The Microbiologist will also support the Product release process where required to help ensure that Products are released in a timely manner complying with standards and GMP guidelines.
Dina arbetsuppgifter i huvudsak
• Performance of the microbiology laboratory in routine and non- routine product testing and environmental microbiology testing
• Generation and approval data generated from microbiological testing and to bring any out of specification (OOS) results/trends to the attention of the team manager
• Assist management in investigating out of specification/trend results for microbiological data as well as identifying and developing corrective actions for out of compliance issues
• Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment
• Execute microbiological validations as needed for products and processes
• Ensure products and processes with Micro laboratory comply with procedures and the principles of GMP
• Support and assist in internal and external audit program.
• Conduct training related to environmental control for the Quality and Manufacturing Personnel
• Development of microbial related procedures, controlled documents and processes
• Assist in Risk Management of the microbial systems and processes
• Support facility projects including process development and quality improvement initiatives
• Compliance to Environmental Health and Safety (EHS) requirements
• Support role to the Regional Sterility Assurance personnel with respect of global sterility assurance commitments
• Supporting the development and implementation of the EMPQ sterility Assurance process
• Providing trend review and comment on the EM processes
• Compliance to Good Manufacturing Practices (GMP)
• Compliance to Environmental Health & Safety (EHS) requirements
• Quality of the testing carried out, the results reported, trend analysis product and process improvement initiatives
• Communication of results, trends, OOS reporting in a timely manner both internally and externally
• To contribute and assist in the development of new testing and techniques. To bring in-house testing where possible
• To develop existing techniques and improve the processing and reliability of the testing carried out
• To maintain an up to date knowledge of micro testing and techniques by seeking within and outwardly new levels of competencies.
• To work actively within team initiative within the Lund site and to lead/support Microbial led initiatives
Vem är du?
Essential Requirements:
• Degree in Microbiology or a science with a specialty in Microbiology
• Post qualification experience of at least 2 years
• Knowledge of GMP desirable
• Experience in a Project based environment work desirable
• Experience of implementing changes and process development
• Previous experience in an aseptic manufacturing facility desirable but not essential
• Good problem solving and investigation skills
• Ability to work under pressure and meet deadlines
• Highly motivated self- starter and team worker
• Ability to work in a team-based environment and ability to manage a wide range of specific tasks
• Good organizational, coordination and communication skills
• Be knowledgeable with regards to GMP/GLP and have a GMP background within the pharmaceutical industry
• Be experienced with Quality Control/ Microbiological testing techniques and industry best practice
• Have proven leadership skills in supervision of teams as well as good time management and communication skills
• Be Knowledgeable with regards to continuous improvement techniques and root cause analysis techniques
• Have experience in test and equipment validation
• Knowledge of EP, USP, FDA requirements
Desirable Experiences and Abilities:
• Demonstrate
o Critical thinking and decision making
o Collaboration and teamwork
o Dealing with ambiguity
o Good management and communication skills
o Customer and patient focus
Om verksamheten
This is a a consultant assignment at a global meditech company in Lund until 2021-12-31, with a possibility of extension. During this period you will be employed by Poolia Life Science.
Submit your application today! If you have any questions regarding the consultant assignment feel free to contact us at Poolia Life Science.
Varaktighet, arbetstid
Heltid Tillsvidare
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2021-09-30
Klicka på denna länk för att göra din ansökanFöretagPoolia Sverige AB
Arbetsgivarens referens Arbetsgivarens referens för detta jobb är "61124".
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Poolia Sverige AB (org.nr 556426-7655),
http://www.poolia.se Arbetsplats Poolia Life Science & Engineering AB
Jobbnummer 5983004
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