Quality Assurance Specialist

PCI TRGR Penn Pharmaceutical Services Ltd; Germany (OH); On-site; USD 62,799 - 85,635; Full time

Job summary

PCI TRGR Penn Pharmaceutical Services Ltd. in Grossbeeren, Germany, seeks a Quality Assurance Specialist to ensure GMP-compliant quality assurance across the site.

You will coordinate CAPAs, change controls, and documentation while collaborating across departments to uphold regulatory standards. The role emphasizes drafting and revising SOPs, supporting risk analyses, and contributing to validation and qualification activities as needed.

Qualifications

• 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.

Responsibilities

• Coordination and review of events, deviations, nonconformances and complaints, and requests for corrective and preventive actions (CAPAs).
• Coordination of change controls and follow-up with action owners to ensure timely completion.
• Interdepartmental communication and problem solving in line with European GMP guidelines.
• Draft, revise and review SOPs, work instructions and forms. Participate in risk analyses.
• Support continual improvement processes, validation and qualification activities as required.

Skills

German language

English language

GMP knowledge

MS Office

Regulatory knowledge

Education

Master's degree relevant field

Pharmaceutical/technical field education

Vocational training with experience

Tools

Quality management systems

Job description

## Quality Assurance SpecialistApplylocations: Grossbeeren, GERtime type: Full timeposted on: Posted Todayjob requisition id: JR118971Life 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 advantageousDescription 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.#LI-JP1Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future