Quality Assurance Officer (Ref: SS17)
Cobra Biologics AB / Kemiingenjörsjobb / 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 Quality Assurance Officer, reporting to the Director of Quality. This role is a permanent position.
The successful candidate will be required to work closely with the Operations teams, project managers as well as with other functions within the organization.
The main responsibilities will be to:
• Contribute to development of the quality system within own area of responsibility
• Approve standard operating procedures, validation documentation, reports and other relevant quality-related documents
• Participate in instrument/equipment/facility/computerized system qualification and validation activities
• Approve deviation and investigation reports to ensure that root causes have been identified and appropriate actions are implemented
• Monitor the program for external audits and perform audits of suppliers
• Participate in internal and external inspections
• Work with teams to identify areas for continuous improvement of the quality system and provide quality guidance
Qualifications:
• University degree in scientific subject
• Knowledge and experience of working in a quality assurance role
• In-depth understanding of Good Manufacturing Practises. Experience in interpreting and applying regulations and guidelines
• Experience from working in the pharmaceutical manufacturing industry (preferably biologics)
• Very good understanding of quality assurance in a manufacturing facility (incl equipment and utilities)
• Knowledge of validation of computerized systems
• Good communication, organizational and interpersonal skills
• Ability to work independently
• Quality orientated
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: SS17
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 1424289
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