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. We are looking for a Quality assurance specialist for out team in Grossbeeren (24 months contract). Hauptaufgaben Main responsibilities: Die Stelle des Quality Assurance Specialist im Bereich „Operations“ ist der Stelle des Senior Quality Assurance Specialist - Operations unterstellt und trägt keinerlei Personalverantwortung. Die Hauptverantwortung des Quality Assurance Specialist beinhaltet die Koordination, Überprüfung und Bearbeitung von Events, Abweichungen, Nonconformances, Reklamationen, Anträgen auf Korrektur- und Vorbeugungsmaßnahmen (CAPAs) und Change Controls unter Verwendung des elektronischen Qualitätsmanagementsystems (eQMS) MasterControl. The Quality Assurance Specialist in the “Operations” department is accountable to the Senior Quality Assurance Specialist - Operations position and has no personnel responsibility. The main responsibility of the Quality Assurance Specialist include coordinating, reviewing and processing events, deviations, nonconformances, complaints, requests for corrective and preventive actions (CAPAs) and change controls using the electronic quality management system (eQMS) MasterControl. Kompetenzprofil Competence profile: Abgeschlossenes naturwissenschaftliches Studium (z.B. Chemie, Pharmazie oder Biologie) oder eine abgeschlossene einschlägige Berufsausbildung (z. B. Chemielaborantin, CTA oder PTA). University degree in a science-related field (e.g. chemistry, pharmacy or biology) or completion of relevant vocational training (e.g., chemical laboratory technician, CTA or PTA). Idealerweise zwei Jahre Erfahrung im Bereich Qualitätsmanagementsysteme. Ideally two years of experience in quality management systems. GMP-Kenntnisse oder Kenntnisse in vergleichbaren Regularien sind vorteilhaft. GMP knowledge or knowledge of comparable regulations is advantageous. Gute Kenntnisse in MS Office (Excel, Word und Outlook). Good knowledge of MS Office (Excel, Word and Outlook). Englisch geschäftssicher in Wort und Schrift. Business English (spoken/written). Erfahrung mit QM-Software wünschenswert. Experience with QM software is preferred. Sorgfältige, strukturierte und eigenverantwortliche Arbeitsweise. A meticulous, organized and self-reliant work style. Gute zwischenmenschliche Fähigkeiten und gute Teamfähigkeit. Good Interpersonal skills and good team skills. Starkes Engagement für Qualitätssicherungsgrundsätze. Strong commitment to Quality Assurance principles. Sehr gute Kommunikationsfähigkeit. Very good communication skills. Selbstmotiviert und organisiert. Self-motivated and organised. Aufgabenbeschreibung Description of tasks: Koordination, Überprüfung und Bearbeitung von Events, Abweichungen, Nonconformances und Reklamationen, Anträgen auf Korrektur- und Vorbeugungsmaßnahmen (CAPAs) und der Erstellung von Abschlussberichten. Coordination, review and of processing of events, deviations, nonconformances and complaints, requests for corrective and preventive actions (CAPAs) and the preparation of final reports. Koordination von Change Controls, Weiterverfolgung von Change Control Maßnahmen mit den jeweiligen Maßnahmenverantwortlichen und Sicherstellung des rechtzeitigen Abschlusses. Coordination of change controls, following up on change control actions with respective action owners and ensuring timely completion. 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. Mitwirken beim Erstellen von Risikoanalysen. Participation in the preparation of risk analyses. Unterstützt die kontinuierlichen Verbesserungsprozesse, Validierungs- und Qualifizierungsaktivitäten nach Bedarf. Supports continual improvement processes, validation and qualiciation activities as required. Unterstützt bei der Erstellung, Überprüfung und Bereitstellung relevanter Metrikdaten des Qualitätssystems für das Management. Supports the creation, review and provision of relevant quality system metrics data to management. Durchführung von administrativen Arbeiten im Qualitätssystem, wie das Pflegen von Listen, Ordnerstrukturen und Logbüchern und Erstellung der monatlichen Statistiken. Carrying out administrative work in the quality system, such as maintaining lists, folder structures and logbooks and preparation of monthly metrics. Unterstützung und Mitwirkung bei Kundenaudits und behördlichen Inspektionen und bei Maßnahmen nach Bedarf. Supports and assists with customer audits and regulatory inspections and actions as required. Übernahme zusätzlicher Qualitätsaufgaben auf Anweisung des Vorgesetzten zur Unterstützung der Geschäftsanforderungen. Undertake additional quality tasks as directed by Line Manager to support business demands. 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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