Documentation Specialist - GMP (Ref: SS18)
Cobra Biologics AB / Kemistjobb / Södertälje
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hela Sverige As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone development services, stretching from cell line development through to the commercial supply of investigational medicinal products. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.
We are currently looking to recruit a Documentation Specialist to the Quality Assurance team. This role is a permanent position.
The successful candidate will be required to work closely with and support the operations teams, project managers as well as other functions within the organization.
The main responsibilities will be to:
• Manage the document system and distribution of documents
• Organize and maintain the archives
• Administer the Standard Operating Procedure system
• Monitor the vendor assurance program and participate in the release of GMP materials
• Perform periodic review within own area of responsibility
• Participate in inspections by authorities and customers
• Administer access to GMP areas and buildings
• Participate in internal improvement projects and monitor KPIs
Qualifications:
• Education in scientific subject
• Experience in pharmaceutical/biotech or other GMP-regulated industry
• Knowledge of GMP regulations and concepts, particularly documentation practices
• Skill and comfort with computer applications
• Ability to work accurately, follow instructions and handle multiple priorities
• Strong organizational and communication skills
• Service minded
The position will be based at the Södertälje site.
Applications should be sent in writing stating the appropriate reference number with full C.V. to:
Jenny Sandberg, PA, Cobra Biologics, email;
jenny.sandberg@cobrabio.comCLOSING DATE: 15 January 2013
Publiceringsdatum2012-12-21Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Så ansöker duSista dag att ansöka är 2013-01-15
Ange följande referens när du ansöker: SS18
Ansökan kan skickas till e-postadress:
jenny.sandberg@cobrabio.comKontaktMaria Krook, Manager Quality 0855250522
maria.krook@cobrabio.comFöretagCOBRA BIOLOGICS AB
AdressCOBRA BIOLOGICS AB
GÄRTUNAVÄGEN 10
15257 SÖDERTÄLJE
KontorsadressGÄRTUNAVÄGEN 10
SÖDERTÄLJE
Övriga kontaktuppgifterTelefonnummer: 08-55250500
Jobbnummer 1424175
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