Join PolyPeptide Group as a Global QA Specialist within computerized Systems and help shape the future of peptide-based pharmaceuticals. Bring your expertise in GMP, computer system validation, and regulatory compliance to a fast-paced, innovative environment supporting digitalization projects worldwide. We value trust, innovation, and excellence, and offer opportunities to grow alongside our international team. Ready for your next challenge? Apply now!
About us
PolyPeptide Group AG and its consolidated subsidiaries (“PolyPeptide”) is a specialized Contract Development & Manufacturing Organization (CDMO) for peptide- and oligonucleotide-based active pharmaceutical ingredients. By supporting its customers mainly in pharma and biotech, it contributes to the health of millions of patients across the world. PolyPeptide serves a fast-growing market, offering products and services from pre-clinical through to commercial stages. Its broad portfolio reflects the opportunities in drug therapies across areas and with a large exposure to metabolic diseases, including GLP-1. Dating back to 1952, PolyPeptide today runs a global network of six GMP-certified facilities in Europe, the U.S. and India. PolyPeptide’s shares (SIX: PPGN) are listed on SIX Swiss Exchange.
Our Values
Trust: We build and maintain trust in all our relationships – both with each other and with our customers. We support each other and work as a team.
Innovation: We are curious and driven by finding smart solutions to the challenges we face.
Excellence: We always strive to deliver high quality and adapt to meet the needs of our customers.
About the role
As a global QA specialist working with global computerized systems, 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 able to meet the high demands.
Key responsibilities:
- 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
About you
We believe that you are ready for new and exciting challenges in a global QA role. 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.
Your profile:
- Minimum 5 years’ experience within Pharma or Medical Device industry
- Minimum 3 years’ experience within a quality function
- Bachelor/Master/PhD degree in scientific life sciences, or equal
- Strong understanding of Good Manufacturing Practices (GMP) and regulatory compliance standards.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Excellent written and verbal communication skills in English.
- Auditor qualification is a merit
Find this interesting?
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. We want our business and our co-workers to grow together, so if you like to be part of that, we look forward to your application.
For more information, please contact Ina Altrell, Global Director Quality, at [email protected] or Ulrika Petersson, Global Quality Specialist Computerized Systems at [email protected]. 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 31/8.
