QA Manager
Scandinavian Gene Synthesis AB (SGS DNA) / Organisationsutvecklarjobb / Köping
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Position Description
Scandinavian Gene Synthesis AB (SGS DNA) located in Köping, Sweden is a world leading manufacturer of high-quality oligonucleotides. We produce under GMP conditions mainly for in-vitro diagnostic (IVD) applications. We are focused on international markets for molecular diagnostic and other areas of medical applications like personalized healthcare.
• As the QA Manager you are responsible for the Quality Management System and all related processes of SGS
• Budget and leadership responsibility for a motivated team of coworkers
• Member of SGS management team
Position Requirements
• Ensure GMP work is done in compliance with applicable guidelines (e.g. cGMP, 21 CFR Part 11, ISO9001, ISO13485)
• Runs Quality Assurance Processes (e.g. complaints, deviations, CAPA, changes, etc.)
• Management of projects to improve procedures and establish standards
• Responsible to conduct regulatory inspections and customer audits
• Review relevant regulatory submissions
• Give guidance and day-to-day support for the QA team
Personal Requirements
• 3 + years Quality Assurance experience for a Medical Device manufacturer
• Degree in a biological, chemistry or comparable disciplines
• Good knowledge about - cGMP, FDA 21 CFR 820
• Proofed Leadership skills
• Effectively communication and negotiation skills
• Effective decision making
• Good knowledge of MS office, ideally experiences with QMS software, LIMS
• Good English knowledge ,fluent in spoken and written
• Preferably knowledge about LEAN and Continuous Improvement Processes
Varaktighet, arbetstid
Duration: unlimited after 6 moth probation period
Publiceringsdatum2017-11-06Så ansöker duSista dag att ansöka är 0001-01-01
FöretagScandinavian Gene Synthesis AB (SGS DNA)
AdressScandinavian Gene Synthesis AB (SGS DNA)
Box 91
73122 KÖPING
KontorsadressJärnvägsgatan 11
Jobbnummer 3787452
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