Validation Specialist, Computerized Systems
PolyPeptide Laboratories (Sweden) AB / Kemistjobb / Malmö
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hela Sverige Visa alla jobb hos PolyPeptide Laboratories (Sweden) AB i Malmö Do you have a passion for continuous improvements and want to join us on our pursue for more digitalized solutions? Do you have a strong technical knowledge within validation of computerized systems? Join our team at PolyPeptide Laboratories AB! We are now looking for a new team member specialized in validation of computerized systems to our Validation department in Malmö. The Validation department has the responsibility for validation activities of computerized systems, production and analytical equipment as well as manufacturing and cleaning processes. As a Validation Specialist at PolyPeptide you will be a part of a competent and service-minded team that interacts with several parts of the organization in a support role. For this specific position your main contact areas will be Production, QC, IT and QA. Most of the work is performed in project teams characterized with high team spirit and good collaboration. About the position
As a Validation Specialist within Computerized Systems your main responsibilities will be to:
• Participate in internal projects as a representative for the Validation department and Subject Matter Expert (SME) related to Computerized System Validation (CSV) - Prepare validation documents (risk assessments, test plans and scripts, validation plans and reports etc.) - Coordinate validation activities together with other departments - Review and approve validation documents - Prepare Standard Operating Procedures (SOP) and policies regarding validation - Act as support during customer and regulatory inspections
Requirements for the position
• B.Sc. in a scientific discipline, or equivalent experience - At least 3 years GMP-experience from the Life Science industry - Experience in validation of computerized systems - Strong knowledge of Good Automated Manufacturing Practice (GAMP) and 21 CFR Part 11 compliance - Fluent in English, in speaking and in writing
Personal qualifications
• High attention to details and good report-writing ability - Good communication skills and a service-minded approach - Handle multiple projects and be able to work independently as required
What we offer
We offer an interesting and dynamic position in an international growing and diverse company with dedicated and skilled colleagues. If you are ready for your next challenge and want to work in an environment where you will be part of a great team this could be the right position for you.
Apply now!
We want our business and our co-workers to grow together, so if you are passionate about validation, we look forward to your application.
For more information, please contact Katarina Herrmann, Manager Validation at 040-366201. For union information contact the local union chairman for Akademikerföreningen or Unionen, please call 040-36 62 00 for support.
We will continuously review applications so please submit your application as soon as possible. Latest day to apply is 11 November 2019.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2019-10-17ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2020-04-04
Klicka på denna länk för att göra din ansökanFöretagPolypeptide Laboratories (Sweden) AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Polypeptide Laboratories (Sweden) AB (org.nr 556389-7254),
http://www.polypeptide.com Arbetsplats PolyPeptide Sweden
Jobbnummer 4877431
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