Global QA Specialist Computerized Systems
PolyPeptide Laboratories (Sweden) AB / Datajobb / Malmö
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hela Sverige Visa alla jobb hos PolyPeptide Laboratories (Sweden) AB i Malmö Are you looking for your next challenge and want to be part of making a difference for people around the world? Do you want to be part PolyPeptides digitalization journey and build a strong fundament to enable efficiency and harmonization globally within QA ? Check out this opportunity!
ABOUT US
PolyPeptide is one of the world's leading independent contractual manufacturer of therapeutic peptides for medicine and cosmetics. The PolyPeptide Group is present with sites in Switzerland, France, Belgium, India, Sweden, and US and employs approximately 1100 co-workers. The Group is listed on the Swiss stock exchange and manufactures more than a third of all approved peptide substances for medicine in the world. We are now looking for Global QA Specialists to our Global QA team.
ABOUT THE ROLE
As a global QA specialist, you will be responsible for ensuring that global policies and SOPs concerning data integrity are in place and are in compliance with cGxP and other regulations, and that global computerized systems are in compliance with internal policies and procedures. You will have both a strategic and an operational focus when being involved in many parts of our business and need to navigate in an environment that has a high tempo and is changeable to able to meet the high demands.
Main duties as Global QA Specialist Systems:
• Ensure GMP compliance and harmonization of global procedures for the global GMP related computerized systems
• Actively support digitalization projects.
• Actively support validation of GMP related computerized systems
• Support preparation of life cycle documentation for GMP related computerized systems, e.g., procedures, risk assessments, validation documents, periodic reviews, change requests
• Support in audits by authorities and customers of PolyPeptide
• Support in qualification of vendors
ABOUT YOU
We believe that you are ready for new and exciting challenges as a global QA specialist. You have several years of experience with QA work and validation of computerized systems within the pharma or medical device industry. You have high GMP understanding as well as knowledge of regulatory requirements, and guidelines related to computerized systems and GMP compliance (e.g., 21 CFR Part 11, Data integrity, GAMP 5).
You enjoy supporting and coach co-workers but are also able to challenge procedures and introduce alternative options. Finally yet importantly, you are strong in communication, to take the next step.
You need to have:
• Minimum 5 years' experience within Pharma or Medical Device industry
• Minimum 3 years' experience within a quality function
• Excellent communications skills in English
• Bachelor/Master/PhD degree in scientific life sciences, or equal
• Auditor qualification is a merit
You will be part of the global team and work with teams on all sites which means that there will be some traveling connected to this position as well as flexible working hours due to time differences. The base for the position is Malmö and here you will have both local and global collegues that work togheter with you against common goals. On our agenda we have a continues growth and want business and our co-workers to grow together! If you want to be part of that, we look forward to your application.
For more information, please contact Ulrika Petersson, Global Quality Specialist Computerized Systems. For union information contact the local union chairman for Akademikerföreningen or Unionen, please call 040-36 62 00 for support. We will review applications ongoing so please submit your application as soon as possible. Latest day to apply is 2022-08-20.
Varaktighet, arbetstid
Heltid Anställningstid enligt överenskommelse
Publiceringsdatum2022-08-05ErsättningLön enligt överenskommelse
Så ansöker duSista dag att ansöka är 2023-01-22
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
Kontakt Barbara Willkomm
barbara.willkomm@polypeptide.com +4640366255 Jobbnummer 6862766
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