Snr. Manager Microbiology & Aseptic Technique to Fresenius Kabi,
Dfind Science & Engineering AB / Biologjobb / Uppsala
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Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. Our products and services are used to help care for critically and chronically ill patients. The company develop, produce and market pharmaceuticals and medical devices. Fresenius Kabi employs more than 33,000 people worldwide and is now recruiting a Senior Manager within Microbiology and Aseptic Technique to the site in Uppsala.
The main purpose of this function is to develop processes and provide training, assessments, advice, guidance and hands-on support in order to close possible compliance gaps in the company's microbiology laboratories and sterile/aseptic manufacturing plants all around the world. The position is stationed in Uppsala, but since it is a global role it includes worldwide travels about 50% of the time.
As a Senior Manager in this role you will be responsible for:
• The establishment of training documentation that can be used for on-site, off-site and digital training courses for employees of different knowledge/experience levels in the field of microbiology and aseptic technique.
• The development and review of global SOPs, Guiding Documents and Templates in the field of microbiology and aseptic technique.
• On- and off-site assessments and support in quality improvement/remediation/built-up tasks in the area of microbiology and aseptic technique (e.g. manufacturing processes, cleanroom gowning processes, media fill).
• Providing support and advice (as based on suitable requirements, guidelines and FK standards) to the Global Operations and the local QA, QC and plant teams in order to close possible compliance gaps in the microbiological laboratory or in aseptic manufacture and to further enhance and develop local skills and knowledge in that area.
• The review and challenge of plant documents/reports in the field of microbiology and aseptic technique.
• Summarizing and analysis of microbiological Q-KPIs, preparation for Q-KPIs meetings and follow-up with the respective plants.
Qualifications:
You have a MSc in Microbiology or in other similar fields of Biology, and a relevant PhD degree is highly preferred for the position. The role requires extensive experience in the pharmaceutical Quality Assurance and/or Quality Control environment, and in order to be successful in this role you need to have substantial knowledge regarding the requirements and application of pharmaceutical quality systems, EU GMP, WHO GMP, CFR210/211, ISO 9001 and other relevant standards. You possess a deep knowledge in pharmaceutical microbiological- and aseptic processes and compliance of equipment and data generation to EU Annex 11 and CFR part 11. You have experience from working in an international environment, and you are expected to demonstrate a high ability to cooperate with and to lead/guide people from other countries and cultures. Moreover, we see that you have experience from inspections/audits of Quality systems, microbiological laboratories and aseptic manufacturing processes.
As a person you are responsible, self-motivated and you thrive on a high level of activity in a networking, global role. You work independently, methodologically and with structured planning allowing for early communication upon signs of not being able to deliver in a timely manner. The position requires excellent verbal and written communication skills in English.
This is a very interesting opportunity for a highly flexible, globally orientated and result-driven individual with broad microbiological background and excellent communication skills. If you are interested in this position and your profile matches the above requirements we are looking forward to receiving your application.
Employer: Fresenius Kabi
City: Uppsala
Type of employment: Full-time
Last day for application: 22nd of January
For information: In this recruitment process Fresenius Kabi is collaborating with Dfind Science and Engineering AB. If you have any questions regarding the position, please contact recruitment consultant Stefan Grip, 073-343 41 45. You are welcome to register your application at
www.dfind.se/science-engineering, 22nd of January at the latest. Selection and interviews will be ongoing during the whole application period, so please register your application as soon as possible.
Company description:
Fresenius Kabi is a leading international health care company focusing on products for the therapy and care of critically and chronically ill patients inside and outside the hospital. The product portfolio comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products. Within transfusion technologies, Fresenius Kabi offers products for whole blood collection and processing as well as for transfusion medicine and cell therapies.
www.fresenius-kabi.com.Varaktighet, arbetstid
Heltid Tillsvidare
Publiceringsdatum2016-12-09ErsättningFast lön
Så ansöker duSista dag att ansöka är 2017-01-22
Ange följande referens när du ansöker: 201007865
Klicka på denna länk för att göra din ansökanKontaktStefan Grip
stefan.grip@dfind.seFöretagDfind Science & Engineering AB
AdressDfind Science & Engineering AB
Gamla Torget 5
75320 UPPSALA
KontorsadressGamla Torget 5, 75320 UPPSALA
Jobbnummer 3206466
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