Quality Assurance Specialist

TN Germany; Großbeeren; Vor Ort; EUR 40.000 - 70.000; Vollzeit

Zusammenfassung

Ein etabliertes Unternehmen im Bereich pharmazeutische Dienstleistungen sucht einen Quality Assurance Specialist, um sicherzustellen, dass alle Prozesse und Ausrüstungen den höchsten Qualitätsstandards entsprechen. In dieser Rolle sind Sie verantwortlich für die Qualifizierung und Validierung von Geräten, die Durchführung von Risikoanalysen und die Erstellung von Dokumentationen. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und Teil eines dynamischen Teams werden möchten, ist dies die perfekte Gelegenheit für Sie, um einen echten Unterschied zu machen.

Qualifikationen

• 2-3 Jahre Erfahrung in qualitätsbezogenen Rollen, idealerweise in der Pharmaindustrie.
• Erfahrung in der Qualifizierung und Validierung von Prozessen und Ausrüstung.

Aufgaben

• Qualifizierung und Validierung von Geräten und Prozessen.
• Erstellung und Überprüfung von Qualifizierungsdokumenten.
• Koordination mit anderen Abteilungen zur Projektförderung.

Kenntnisse

Qualitätssicherung

Risikomanagement

GMP-Anforderungen

Dokumentation

Analytische Fähigkeiten

Ausbildung

Bachelor in Pharmazie oder verwandtem Bereich

Jobbeschreibung

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Quality Assurance Specialist, Grossbeeren

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Client:

PCI Pharma Services

Location:

Job Category:

Other

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EU work permit required:

Yes

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Job Reference:

03fe3a031223

Job Views:

2

Posted:

06.05.2025

Expiry Date:

20.06.2025

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Job Description:

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 currently hiring a Quality Assurance Specialist to join our team in Grossbeeren, Germany.

Main responsibilities:

• Qualification and validation of equipment, facilities, utilities, processes.
• Conducting risk analyses of new production processes.
• Creating and reviewing qualification and validation documents (URS, DQ, IQ, OQ, PQ).
• Creating process documentation and evaluating the results.
• Coordination and cooperation with other departments to drive projects forward in a target-oriented manner.
• Availability for audits on the topics of qualification and validation.
• Change control and deviation management.
• Implementation of the defined quality objectives.
• Structuring and monitoring of quality tasks you initiated.
• Assist in the execution of tasks related to the daily aspects of Quality Assurance.
• Develop and review SOPs, work instructions and forms.
• Preparation of qualification and/or validation documents related to instruments, equipment, facilities (including cold storage), utilities, manufacturing and cleaning processes, including URS, risk analysis, IQ, OQ, MQP, PQ.
• Review and adhere to the site qualification master plan.
• Establish and monitor a register of equipment to be qualified and validated.
• Discuss validation requirements for new orders with customers.
• Assigning appropriate corrective actions and implementing them in a timely manner.
• Conduct periodic reviews and re-qualifications with ongoing process reviews.
• Assist with all regulatory inspections, customer visits and customer audits related to qualification and validation related issues as required.
• Training and supporting employees in terms of qualification / validation topics.

Experience and Qualifications:

• 2-3 Years’ Experience within a quality systems related role (ideally pharma related).
• Proven expertise in qualification and validation of rooms, equipment, processes and utilities.
• Ability to run temperature mappings.
• Demonstrable experience within Quality department, ideally in a packaging or pharmaceutical company.
• Good knowledge of Quality Assurance inspection requirements.
• Risk Analysis and associated methodology.
• Trained in GMP requirements.
• Fluent in business English and German (in speech and writing).
• Good interpersonal and Teamwork skills.
• Strong commitment to Quality Assurance principles.
• Analytical approach / attention to detail.
• Self-motivated and organised.

#LI-VR1

Join us and be part of building the bridge between life changing therapies and patients.