Global QA Specialist within Computerized Systems

2 weeks ago

Malmö, Sweden PolyPeptide Sweden Full time

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 of PolyPeptides digitalization journey and build a strong fundament to enable efficiency and harmonization globally within QA? PolyPeptide is on an exciting growth journey, and we are strengthening our Global QA Team with the addition of a Global QA Specialist

ABOUT US

PolyPeptide is one of the world’s leading independent contractual manufacturers 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 1200 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.

ABOUT THE ROLE

As a global QA specialist within Computerized Systems, you will be responsible for ensuring that global computerized systems are in compliance with internal policies and procedures. You will have 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 be able to meet the high demands.

Main duties

  • 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., validation documents, periodic reviews, change requests, deviations, risk assessments, procedures
  • Support in audits by authorities and customers of PolyPeptide
  • Support in qualification of software vendors

YOUR PROFILE

  • Bachelor/Master´s/PhD degree in sciences or equivalent
  • Minimum 5 years’ experience within Pharma or Medical Device industry
  • Minimum 3 years’ experience within a quality function
  • Fluent in English, Swedish/Danish a plus as the role is located at the Swedish site in Malmö
  • 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)
  • Experience with audits is a merit

To thrive in this role, you enjoy taking great ownership of your tasks. Furthermore, you have an ability to work in a structured and methodical way in your work so that it is carried out in an efficient and correct way. You have an open attitude towards other people and see value in collaborating. In addition, you always look out for the group's best interests and are keen to create a good working climate, where you are happy to support your colleagues when needed.

Does this sound like an exciting challenge?

PolyPeptide offers a great work environment where our co-workers and business are allowed to grow together. We have an open and welcoming atmosphere and are proud of our workplace since we work with the purpose of making life better for patients around the world.

If you enjoy challenges and find it rewarding to influence and improve, we hope that you will find this position intriguing. The position will be open for application to 2024-06-02. If you are interested, please submit your application, your CV and preferably a personal letter as soon as possible. We will review the applications ongoing. For additional information regarding this position please contact Ina Altrell, Global Director Quality, at Ina.Altrell@polypeptide.com or Ulrika Petersson, Global Quality Specialist Computerized Systems, at Ulrika.Petersson@polypeptide.com.

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