QASystems Manager(m/f/d)

pbunisite ag /b is a service provider in the field of Employer Branding Talent Management. We provide consulting services to clients in the chemistry, pharmaceutical, biotech, medical device, and life sciences industries. /ppOur client, bPentapharm AG /b, is a Swiss SME with a long-standing tradition as an innovative and reliable supplier of active ingredients for the personal care, pharmaceutical and haemostasis diagnostics industries. /ppOn behalf of our client, we are currently looking for a: /ph3Position /h3pFor the Quality Assurance team, we are looking for an experienced and hands-on bQA Systems Manager (m/f/d) /b to ensure the effective operation and continuous compliance of our Quality Management System. /ppIn this role, you will take ownership of key QA systems and processes, including eQMS and training management, Quality Agreements, complaints and Product Quality Reviews. You will work closely with internal stakeholders and external partners to ensure compliance with applicable GMP/GDP requirements. /ph3Tasks /h3ulliAdminister and maintain the electronic Quality Management System (eQMS) and electronic training management system, including document control, user access, training records and related QA system activities /liliSupport onboarding and offboarding activities related to training assignments and eQMS access /liliCoordinate Quality Agreements with customers and suppliers, including preparation, review, approval and periodic updates /liliCoordinate the maintenance and periodic review of the Site Master File /liliInitiate and coordinate annual Product Quality Reviews (PQRs), including cross-functional data collection and follow-up /liliManage customer complaints and coordinate investigations and related CAPA activities /liliSupport Change Control assessments as the Quality representative /liliPrepare and review QA-related sections of customer quality questionnaires /liliSupport customer audits and regulatory inspections, including preparation, back-office coordination and follow-up of observations /liliEnsure QA systems and documentation remain compliant with applicable GMP/GDP requirements and data integrity principles /li /ulh3Qualification /h3ulliMSc in Biology, Chemistry, Pharmacy, Quality Management or a related scientific field /lili10+ years of professional experience in a GMP- or ISO-regulated production environment /liliStrong knowledge of GMP requirements and Quality Management Systems /liliPractical experience with eQMS and electronic document management systems /liliSound knowledge of key quality processes, including complaints, CAPA, Change Control, training management and audits /liliFamiliarity with pharmaceutical quality standards and regulatory requirements; basic knowledge of IVDR is an advantage /liliStrong organizational skills and a structured, detail-oriented approach to work /liliAbility to work independently, take ownership and collaborate effectively across functions /liliVery good communication skills in German and English /liliConfident user of common IT systems and digital quality tools /li /ul #J-18808-Ljbffr