QA Specialist, Validation
Scandinavian Gene Synthesis AB (SGS DNA) / Kemiingenjörsjobb / Köping
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hela Sverige We are looking for QA Specialist, working with regular processes related to the quality management system of SGS DNA, and with a responsibility for the validation process in addition. You will be working in a team of 5 motivated and highly skilled employees.
Position Requirements
• Responsibility for conducting and planning validation/qualification for equipment, methods, processes, facility and software, etc.
• The company 's main competence in regulations and requirement regarding validation.
• To perform validation work at SGS DNA according to existing procedures
• To develop procedures for validation and qualification
• To work according to SGS DNA's policies and procedures
• Review of production records and release of final products
• Work according processes and ownership of a process in the QMS (e.g. deviation handling, CAPA, change management, validation, etc.)
• Participation in improvement projects
Personal Requirements
• Quality minded
• With scientific or academic background
• Verifiable first experiences ( 1-3 years) in QC/ QA with validations or related tasks, ideally in the GMP environment alternatively equivalent work experience
• Team player
• Preferable knowledge and/or experience in GAMP5, ISO 13485, cGMP 21 CFR 820 and clean room requirements
• Good knowledge of MS office is required, ideally experiences with QMS software, LIMS and MS SharePoint or similar systems
• Fluent in writing and speaking Swedish and English
• Preferably knowledge about LEAN and Continuous Improvement Processes
Scandinavian Gene Synthesis AB (SGS DNA) located in Köping, Sweden is a world leading manufacturer of high-quality oligonucleotides. We are mid-size company that produces synthetic DNA under GMP conditions mainly for in-vitro diagnostic (IVD) applications. We are following requirements in 21 CFR 820 for Medical Devices, ISO 13485 and ISO 9001. We are focused on international markets for molecular diagnostic and other areas of medical applications like personalized healthcare.
Varaktighet, arbetstid
The emmployment is unlimited after 6 moth probation period
Publiceringsdatum2018-02-15Så ansöker duSista dag att ansöka är 2018-03-15
Ange följande referens när du ansöker: QA Specialist Validation 1802
KontaktLena Q Olsson
lena.q.olsson@sgsdna.com 022129677
FöretagScandinavian Gene Synthesis AB (SGS DNA)
AdressScandinavian Gene Synthesis AB (SGS DNA)
Box 91
73122 KÖPING
KontorsadressJärnvägsgatan 11
Jobbnummer 3967140
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