Sterility Assurance Lead
Dfind Science & Engineering AB / Biologjobb / Lund
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Do you want to take part in Baxter 's new aseptic manufacturing in Lund? Are you an expert within sterility quality assurance and like to work with continues improvements? Do you want to work for a global company where you every day have the chance to save and sustain people 's lives? If your answer is yes, you may be the candidate we are looking for!
Baxter will start up a new innovative extempore manufacturing in Lund where you will contribute with sterility assurance, planning and implementing guidelines to the local organization.
As Sterility Assurance Lead you ensure periodic quality reviews and are responsible for development, management and trending the Environment Monitoring (EM) program. You qualify, audit and monitor the service level of external laboratories, providing oversight on technical aspects. You provide support from a microbiological perspective to validation activities, lead risk reduction and continues improvement initiatives. You carry out validation and experimental design in association with EMEA Sterility Assurance Manager. Your responsibilities also include review and disposition of routine of laboratory test data. You work closely with the aseptic manufacturing to ensure the product meets specification and customer expectations on delivery and quality in a microbiological perspective. You will be fully integrated in the Global Baxter QA organization for Compounding and work with the regulatory requirements GMP, GDP and EHS.
It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix of people. Joining Baxter means joining a team that you can truly learn from!
We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you.
If you want to learn more about career opportunities go to
http://www.baxter.com/careers.pageQualification:
We are looking for a person with the following experience and qualification:
• Master of Science in preferably microbiology or similar
• Minimum 2 years in similar role at Quality/Microbiological department
• GMP, GDP, EHS knowledge both in theory and experience from the industry
• Used quality improvement and problem solving tools (i.e. Failure Modes & Effects Analysis (F.M.E.A.), Capability Studies, Process Mapping, DMAIC, PDCA), and the interpretation of data.
• You have excellent English and Swedish in speech and writing.
On a personal level, you have excellent communications skills. You are self-motivated and you have the ability to plan and execute activities with minimal supervision. You have a critical thinking and strives to solve problems. You like to work in a structured way with an eye for details. We place great emphasis on personal qualities for this role.
Company: Baxter
City: Lund
Job type: Full time
Deadline for applications: 2017.06.18
• More information: This recruitment will be managed by Dfind Science & Engineering. For more information about this position please contact Recruitment Consultant Camilla Wern 0733-436098. The selection process is on-going so please apply as soon as possible, however not later than 2017.06.18. Please send in your application in English via
https://www.dfind.se/science-engineering/Organization/Business description:
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Key words: QA, QC, GMP, GDP, EHS, Validation, manufacturing, microbiological control, sterile compounds, extempore, quality, pharma
Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2017-05-24ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-06-18
Ange följande referens när du ansöker: 201056334
Klicka på denna länk för att göra din ansökanKontaktCamilla Wern 0733-436098
FöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Styrmansgatan 2
22363 Malmö
KontorsadressStyrmansgatan 2, 21118 Malmö
Jobbnummer 3520278
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