Global QA Specialist - Computerized Systems

As a Global QA Specialist at PolyPeptide Group, you will play a crucial role in supporting the quality assurance processes of peptide- and oligonucleotide-based active pharmaceutical ingredients. With a focus on global computerized systems, your responsibilities will involve actively supporting digitalization projects, validation of GMP related computerized systems, preparation of life cycle documentation, supporting audits by authorities and customers, and qualification of software vendors. **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. **Qualifications Required:** - 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. PolyPeptide Group offers an exciting opportunity to work at the forefront of peptide-based therapeutics, a rapidly growing and innovative segment of the pharmaceutical industry. By joining the PolyPeptide team, you will have the chance to contribute to a company dedicated to client success and the advancement of peptide science. Become a part of a global organization that is shaping the future of life-saving therapies.,