PCI Pharma Services Germany GmbH
Quality Assurance Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Großbeeren
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PCPCI Pharma Services Germany GmbH
Qualified Person(m/w/x)
Großbeeren
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Batch certification and GMP auditing for sterile and large molecule biopharmaceuticals at global CDMO. Extensive experience in QP certification and EU GMP audits required. International travel for third-country site inspections.
Anforderungen
- Experience in QP certification activities
- Experience in sterile dosage forms
- Experience in non-sterile dosage forms
- Experience in large molecule biopharmaceuticals
- Experience in EU GMP audits
- Experience in pharmaceutical packaging and processing
- Experience working in global organisations
- High level knowledge of GxPs
- Knowledge of Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis principles and methodology
- Eligibility to act as Qualified Person
- Pharmacist degree level education
- Business fluent German and English
- Good interpersonal and interaction skills
- Ability to prioritise competing needs
- Good written communication skills
- Good teamworking and leadership skills
- Ability to coach and mentor staff
Aufgaben
- Maintain compliance with GMP, customer Quality Agreements, and German legal frameworks
- Adhere to LAVG licenses and EU GMP Directives and Guidelines
- Review Batch Manufacturing Documents for EU GMP and marketing authorization compliance
- Certify medicinal products for use inside and outside the EU
- Audit manufacturing sites in EU and third countries for GMP compliance
- Review PCI Project Files to ensure regulatory and procedural compliance
- Contribute to the PCI Quality Management System
- Assist with regulatory inspections and client audits
- Identify and support internal process and procedure improvements
- Support site-wide training for commercial and clinical activities
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GxPs
- Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis methodology
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens PCI Pharma Services Germany GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Noch nicht perfekt?
- ProBioGen AG
Quality Assurance (QA) Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - Carl Zeiss Meditec AG
Referent Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - LGC Group
Teamlead Qualitätssicherung – API-Produktion(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - PCI GER PCI Pharma Services Germany GmbH
Despatch Quality Control Inspector(m/w/x)
Vollzeitnur vor OrtBerufserfahrenGroßbeeren
PCPCI Pharma Services Germany GmbH
Qualified Person(m/w/x)
Großbeeren
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Batch certification and GMP auditing for sterile and large molecule biopharmaceuticals at global CDMO. Extensive experience in QP certification and EU GMP audits required. International travel for third-country site inspections.
Anforderungen
- Experience in QP certification activities
- Experience in sterile dosage forms
- Experience in non-sterile dosage forms
- Experience in large molecule biopharmaceuticals
- Experience in EU GMP audits
- Experience in pharmaceutical packaging and processing
- Experience working in global organisations
- High level knowledge of GxPs
- Knowledge of Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis principles and methodology
- Eligibility to act as Qualified Person
- Pharmacist degree level education
- Business fluent German and English
- Good interpersonal and interaction skills
- Ability to prioritise competing needs
- Good written communication skills
- Good teamworking and leadership skills
- Ability to coach and mentor staff
Aufgaben
- Maintain compliance with GMP, customer Quality Agreements, and German legal frameworks
- Adhere to LAVG licenses and EU GMP Directives and Guidelines
- Review Batch Manufacturing Documents for EU GMP and marketing authorization compliance
- Certify medicinal products for use inside and outside the EU
- Audit manufacturing sites in EU and third countries for GMP compliance
- Review PCI Project Files to ensure regulatory and procedural compliance
- Contribute to the PCI Quality Management System
- Assist with regulatory inspections and client audits
- Identify and support internal process and procedure improvements
- Support site-wide training for commercial and clinical activities
Berufserfahrung
- ca. 1 - 4 Jahre
Ausbildung
- Master-Abschluss
Sprachen
- Deutsch – verhandlungssicher
- Englisch – verhandlungssicher
Tools & Technologien
- GxPs
- Quality Management Systems
- Continuous Improvement methodology
- Risk Analysis methodology
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens PCI Pharma Services Germany GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Über das Unternehmen
PCI Pharma Services Germany GmbH
Branche
Pharmaceuticals
Beschreibung
PCI Pharma Services delivers life-changing therapies globally, bridging biopharma companies and patients. They invest in people to drive progress and shape the future.
Noch nicht perfekt?
- PCI Pharma Services Germany GmbH
Quality Assurance Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahrenGroßbeeren - ProBioGen AG
Quality Assurance (QA) Expert(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - Carl Zeiss Meditec AG
Referent Qualitätsmanagement(m/w/x)
Vollzeitnur vor OrtBerufserfahrenBerlin - LGC Group
Teamlead Qualitätssicherung – API-Produktion(m/w/x)
Vollzeitnur vor OrtSeniorBerlin - PCI GER PCI Pharma Services Germany GmbH
Despatch Quality Control Inspector(m/w/x)
Vollzeitnur vor OrtBerufserfahrenGroßbeeren