QA/QC Manager
Scandinavian Gene Synthesis AB (SGS DNA) / Organisationsutvecklarjobb / Köping
Observera att sista ansökningsdag har passerat.
Visa alla organisationsutvecklarjobb i Köping,
Kungsör,
Arboga,
Hallstahammar,
Surahammar eller i
hela Sverige Visa alla jobb hos Scandinavian Gene Synthesis AB (SGS DNA) i Köping,
Västerås eller i
hela Sverige Scandinavian Gene Synthesis AB (SGS DNA) manufactures synthetic DNA to diagnostic companies and researchers all over the world. We are a high technological company with approximately 50 employees. We are now searching for new collaborators to our facility situated in Köping, Sweden.
QA/QC Manager
Are you an experienced Quality Assurance Professional with Medical Device manufacturing experience? If so, we are looking for a team member to join a Medical Device Manufacturer.
Core Responsibilities:
• Ensure GMP work is done in compliance with applicable guidelines (eg cGMP, 21 CFR Part 11, ISO9001, ISO13485, ISO 14971)
• Runs Quality Assurance Processes (e.g. complaints, deviations, CAPA, changes, training records, etc.)
• Provide quality and compliance oversight of the quality systems.
• Working with operating staff to establish procedures, standards, systems and procedures
• Responsible directly in regulatory inspections, e.g. ISO and FDA.
• Acting as a catalyst for change and improvement in performance/quality
• Track progress versus timelines and goals.
• Review relevant regulatory submissions.
• Responsible for managing tasks associated with Quality Control activities (e.g. testing, inspection)
• Ability to provide administrative and technical direction to quality control personnel
Qualifications:
• 3 + years Quality Assurance experience for a Medical Device manufacturer
• FDA compliance experience with a strong understanding of FDA guidelines and ISO 13485
• Process improvement - cGMP, FDA 21 CFR 820 knowledge
• Bachelor's degree in a biological or chemistry discipline. Other educational experience will be considered in conjunction with work experience.
• Proven ability to work in a team environment, balancing compliance risk with business need.
Important skills;
• Creative thinking and problem solving,
• Process improvement,
• Effective verbal and written communication
• Emphasizing excellence and thoroughness,
• Dealing with complexity
• MS Word, Excel, PowerPoint
• Attention to detail
We can offer you a job with challenging and engaging projects in an interesting company with great prospects.
Please send your application with CV to
work@sgsdna.com . The selection will be ongoing during the application period
Publiceringsdatum2014-09-08Arbetstider och omfattningTillsvidare
Heltid
ErsättningFast lön
Individuell lönesättning
Så ansöker duSista dag att ansöka är 2014-10-08
Ange följande referens när du ansöker: 14/2
Ansökan kan skickas till e-postadress:
work@sgsdna.comKontaktPetra Fridström, Manager QA/QC 0221-29655 070-339 90 61
petra.fridstrom@sgsdna.comFöretagScandinavian Gene Synthesis AB (SGS DNA)
AdressScandinavian Gene Synthesis AB (SGS DNA)
Box 91
73122 KÖPING
KontorsadressJärnvägsgatan 11
Övriga kontaktuppgifterTelefonnummer: 0221-29650
Faxnummer: 0221-29669
Jobbnummer 1989568
Observera att sista ansökningsdag har passerat.