Quality Assurance Specialist

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.

Hauptaufgaben main responsibilities:

Die Stelle des Quality Assurance Specialist ist der Stelle des Senior Quality Assurance Specialists unterstellt und trägt keinerlei Personalverantwortung. Die Hauptverantwortung des Quality Assurance Specialist beinhaltet die Sicherstellung der Erfüllung der Qualitätssiccherungsanforderungen gemäß dem GMP-Leitfaden, den Kundenanforderungen und sonstigen Vorgaben aus Zertifizierungen des Standortes.

Kompetenzprofil:

• Abgeschlossene Berufsausbildung mit mehrjähriger einschlägiger Erfahrung oder Masterabschluss oder vergleichbar im pharmazeutischen, naturwissenschaftlichen oder technischen Bereich
• Gute Deutsch- und/oder Englischkenntnisse in Wort und Schrift
• Gute Kenntnisse in MS Office (Excel, Word und Outlook)
• GMP-Kenntnisse oder Kenntnisse in vergleichbaren Regularien sind vorteilhaft

Aufgabenbeschreibung:

• Koordination und Überprüfung von Events, Abweichungen, Nonconformances und Reklamationen, Anträgen auf Korrektur- und Vorbeugungsmaßnahmen (CAPAs) und der Erstellung von Abschlussberichten.
• Koordination von Änderungskontrollen; Weiterverfolgung von Änderungskontrollmaßnahmen mit den jeweiligen Maßnahmenverantwortlichen und Sicherstellung des rechtzeitigen Abschlusses
• Abteilungsübergreifende Kommunikation und Problemlösung unter Berücksichtigung der europäischen GMP-Richtlinien.
• Erstellung, Überarbeitung und Überprüfung von SOPs, Arbeitsanweisungen und Formularen.
• Mitwirken beim Erstellen von Risikoanalysen.
• Unterstützt die kontinuierliche Verbesserungsprozesse, Validierungs- und Qualifizierungsaktivitäten nach Bedarf.
• Durchführung von administrativen Arbeiten im Qualitätssystem, wie das Pflegen von Listen, Ordnerstrukturen und Logbüchern und Erstellung der monatlichen Statistiken.

The Quality Assurance Specialist is accountable to the Senior Quality Assurance Specialist position and has no personnel responsibility. The main responsibility of the Quality Assurance Specialist is to ensure fulfilment of the quality assurance requirements in accordance with the GMP guidelines, customer requirements and other specifications from site certifications.

Competence profile:

• Completed vocational training with several years of relevant experience or Master’s degree or equivalent in the pharmaceutical, scientific or technical field.
• Completed vocational training with several years of relevant experience or Master’s degree or equivalent in the pharmaceutical, scientific or technical field
• Good written and spoken German and/or English skills
• Good knowledge of MS Office (Excel, Word and Outlook)

• GMP knowledge or knowledge of comparable regulations is advantageous

Description of tasks:

• Coordination and review of events, deviations, nonconformances and complaints, requests for corrective and preventive actions (CAPAs) and the preparation of final reports.
• Coordination of change controls; following up on change control actions with respective action owners and ensuring timely completion.
• Interdepartmental communication and problem solving in due consideration of the European GMP guidelines.
• Draft, rework and review of SOPs, Work Instructions and forms. Participation in the preparation of risk analyses.
• Supports continual improvement processes, validation and qualification activities as required.
• Carrying out administrative work in the quality system, such as maintaining lists, folder structures and logbooks and preparation of monthly metrics.

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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.