Quality Assurance Specialist m/f/d
PCI GER PCI Pharma Services Germany GmbH
Großbeeren, Germany21h ago
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Key details
- Location
- Großbeeren, Germany
- Work style
- Onsite
- Level
- Mid level
- Job type
- Full-time
- Experience
- 2–5 yrs
- Function
- Operations & Strategy
- Focus area
- other
- Posted
- 21h ago
Skills
About the role
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.