Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Quality Assurance Specialist (m/f/d) We are looking for a Quality Assurance Specialist to join our Operations team in Grossbeeren. In this role, you will support the maintenance and continuous improvement of our Quality Management System while ensuring compliance with GMP and regulatory requirements. Key Responsibilities Manage and review deviations, nonconformances, complaints, CAPAs, and change controls using the eQMS (MasterControl) Coordinate quality-related investigations and ensure timely completion of actions Prepare and review SOPs, work instructions, and quality documentation Support risk assessments, continuous improvement initiatives, and quality metrics reporting Collaborate cross-functionally to ensure GMP compliance Assist during customer audits and regulatory inspections What We're Looking For Degree in a scientific discipline (e.g., Chemistry, Biology, Pharmacy) or relevant vocational qualification Ideally 2+ years of experience in Quality Assurance or Quality Management Systems Knowledge of GMP or similar regulated environments Experience with quality management software is an advantage Strong organizational, communication, and problem-solving skills Proficiency in MS Office and business-level English. German is an added plus. If you are a detail-oriented quality professional who enjoys working in a regulated environment, we'd love to hear from you. Quality Assurance Specialist (m/w/d) Für unseren Standort in Großbeeren suchen wir einen Quality Assurance Specialist (m/w/d) zur Unterstützung unseres Operations-Teams. Ihre Aufgaben Bearbeitung und Koordination von Abweichungen, Nonconformances, Reklamationen, CAPAs und Change Controls im eQMS (MasterControl) Unterstützung bei Untersuchungen sowie Sicherstellung der termingerechten Umsetzung von Maßnahmen Erstellung, Überarbeitung und Prüfung von SOPs, Arbeitsanweisungen und Qualitätsdokumenten Mitwirkung bei Risikoanalysen, Qualitätskennzahlen und kontinuierlichen Verbesserungsprozessen Enge Zusammenarbeit mit verschiedenen Fachbereichen zur Sicherstellung der GMP-Compliance Unterstützung bei Kundenaudits und behördlichen Inspektionen Ihr Profil Abgeschlossenes naturwissenschaftliches Studium oder eine relevante Berufsausbildung Idealerweise mindestens 2 Jahre Berufserfahrung im Qualitätsmanagement oder in der Qualitätssicherung Kenntnisse der GMP-Anforderungen oder vergleichbarer Regularien von Vorteil Erfahrung mit Qualitätsmanagement-Software wünschenswert Strukturierte, sorgfältige und selbstständige Arbeitsweise Sehr gute Kommunikations- und Teamfähigkeit Sicherer Umgang mit MS Office sowie Deutsch- und Englischkenntnisse auf Geschäftsebene. Sie arbeiten gerne qualitätsorientiert, übernehmen Verantwortung und fühlen sich in einem regulierten Umfeld wohl? Dann freuen wir uns auf Ihre Bewerbung. Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

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3 Nov, 2026

Pciservices

Sr. JD Edwards User Security & CNC Administrator

Full time
Senior level
Security

IRL_City North, Ireland

Full time

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