QA Officer /QA Värderare, Recipharm i Strängnäs
Recipharm / Kemistjobb / Strängnäs
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Recipharm Strängnäs is a dedicated penicillin (Beta-lactams) manufacturing facility manufacturing tablets, granulates and minitablets in a variety of finished packed forms. Recipharm Strängnäs currently holds a License from LV for the manufacturing and packaging of authorized medicinal products and clinical trial products. The Quality Assurance officer provides general support in all aspects of the development and maintenance of the Quality Management System supporting; clinical trial manufacture, routine manufacture and analysis of antibiotics. This hands-on QA role is focused on supporting manufacturing and supply chain operations, facilitating their effective compliance with GMP.
The role consists of:
• Maintenance, implementation and continuous improvement of the QMS
• Bulk and Finished product batch review
• Release of APIs, excipients, primary and secondary packaging materials.
• Performing & documenting non-conformance and deviation investigations
• Responding to and investigating customer complaints
• Writing formal customer reports (PQRs, stability, CT reports)
• Active participation in CAPA and CC systems.
• Approval of artworks
• Manufacturing batch protocol updates
The candidate should:
• The candidate should have 3-5 years experience working in a GMP environment and should be up to date with on-going changes within the pharmaceutical industry.
• Be a conscientious and a well-motivated individual
• Have the ability and desire to drive change in order to improve both the systems in which they work, and their own development
• Be able to work independently and actively participate in a team environment.
• Have a strong knowledge of Microsoft software systems coupled with good communication skills
Experience with LIMS, M3 (ERP), Seavision & Tracelink is not essential but beneficial. The opportunity to further educational requirements to attain QP status is a potential scope for development within the role depending on development within the QA structures.
For ruther information or questions about the position, contact recruiting Manager Scott Cooper:
scott.cooper@recipharm.comWelcome to apply for the position no later than August 13, 2018.
About Recipharm
Recipharm is a leading CDMO (Contract Development and Manufacturing Organisation) in the pharmaceutical industry employing some 5,000 employees. Recipharm offers manufacturing services of pharmaceuticals in various dosage forms, production of clinical trial material and APIs, and pharmaceutical product development. Recipharm manufactures several hundred different products to customers ranging from Big Pharma to smaller research- and development companies. Recipharm's turnover is approximately SEK 5.3 billion and the Company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US and is headquartered in Stockholm, Sweden. The Recipharm B-share (RECI B) is listed on Nasdaq Stockholm.
For more information on Recipharm and our services, please visit
www.recipharm.comVaraktighet, arbetstid
Heltid/ Ej specificerat
Publiceringsdatum2018-06-19Ersättningmånadslön
Så ansöker duSista dag att ansöka är 2018-08-13
Klicka på denna länk för att göra din ansökanFöretagRecipharm
AdressRecipharm
Mariefredsvägen 35
64541 Strängnäs
KontorsadressMariefredsvägen 35
Jobbnummer 4211629
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