Quality Assurance Technician

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.

Die Assistenz in der Qualitätssicherung unterstützt das Qualitätssicherungsteam in administrativer und technischer Hinsicht.

Quality Assurance Technician provides administrative and technical support to the Quality Assurance team.

Durchführung von administrativen Arbeiten im Qualitätssystem, wie das Pflegen von Listen, Ordnerstrukturen und Logbüchern.

Carrying out administrative work in the quality system, such as maintaining lists, folder structures and logbooks.

Abteilungsübergreifende Kommunikation und Problemlösung unter Berücksichtigung der europäischen GMP-Richtlinien.

Interdepartmental communication and problem solving in due consideration of the European GMP guidelines.

Erstellung, Überarbeitung und Überprüfung von SOPs, Arbeitsanweisungen und Formularen.

Draft, rework and review of SOPs, Work Instructions and forms.

Unterstützen bei der Koordinierung und Überprüfung von Events, Abweichungen, Nonconformances und Reklamationen, Anträgen auf Korrektur- und Vorbeugungsmaßnahmen (CAPAs) und der Erstellung von Abschlussberichten.

Assist in the coordination and review of events, deviations, nonconformances and complaints, requests for corrective and preventive actions (CAPAs) and the preparation of final reports.

Unterstützung bei der Koordinierung des Änderungskontrolle; Weiterverfolgung von Änderungskontrollmaßnahmen mit den jeweiligen Maßnahmenverantwortlichen und Sicherstellung des rechtzeitigen Abschlusses

Assisting in coordination of the change control panel; following up on change control actions with respective action owners and ensuring timely completion

Unterstützung bei der Erstellung der monatlichen Statistiken.

Assisting in the preparation of monthly metrics.

Mitwirken beim Erstellen von Risikoanalysen.

Participation in the preparation of risk analyses.

Übernahme zusätzlicher Qualitätsaufgaben auf Anweisung des Vorgesetzten zur Unterstützung der Geschäftsanforderungen.

Undertake additional quality tasks as directed by Line Manager to support business demands.

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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.