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:
- Verantwortlich für das Audit Management des Standortes
- Responsible for the audit management on site.
- Eigenständige Planung, Durchführung und Verwaltung von Kunden-, Lieferanten-, internen Audits. Betreuung von externen Audits.
- Independently plan and manage customer, supplier, and internal audits. Hosting of external audits.
- Festlegung von Folgemaßnahmen in Zusammenarbeit mit den betroffenen Fachfunktionen. Nachverfolgund und Dokumentation der Maßnahmen.
- Definition of follow-up actions in collaboration with the respective departments. Tracking and documentation of the actions.
- Betreuung des Lieferantenmanagements.
- Supervision of supplier management.
Aufgabenbeschreibung / Description of tasks:
- Planung, Vorbereitung, Durchführung von.
- Planning, preparation, execution and of:
- Kundenaudits/customer audits
- Internen Audits/internal audits
- Lieferantenaudits/supplier audits
- Vorbereitung, Begleitung und Auswertung von:
- Preparation, hosting, and evaluation of:
- Externen Audits (bspw. Behördeninspektionen)/external audits (e.g. authority inspections)
- Unterstützt Erstellung und Durchführung des Internen Auditplans
- Responsible for the internal audit plan and its implementation.
- Erstellung von Auditberichten und Antwortschreiben
- Drafting of audit reports and audit responses.
- Festlegung von Maßnahmen in Zusammenarbeit mit den betroffenen Abteilungen und Nachverfolgung sowie Dokumentation derselben in angemessenen Zeitrahmen
- Definition of actions in collaboration with the respective departments and follow-up as well as documentation of actions in a timely manner.
- Kommunikation von abgeschlossenen Maßnahmen an andere Stellen
- Feedback of completed actions to other parties.
- Unterstützt Lieferantenqualifizierung inclusive Lieferantenaudits
- Support of supplier qualification and supplier audits.
- Bewertung von Lieferanten
- Execution of supplier evaluations.
- Identifizierung von Verbesserungspotentialen
- Identification of improvement opportunities.
- Kommunikation mit allen Beteiligten im Bezug auf Audits und Inspektionen
- Stakeholder management in regard to audits and inspections.
- Unterstützung anderer Qualitätsthemen nach Bedarf
- Support of other quality topics as required.
Fähigkeiten und Erfahrung / Skills and Experience
- Approbation als Apotheker oder vergleichbarer Universitätsabschluss (Biochemie, Chemie, Biologie oder vergleichbar)
- Licensed Pharmacist or comparable University degree in a technical or other related scientific discipline (Biochemistry, Chemistry, Biology).
- Mindestens 5 Jahre Erfahrung mit Qualitätsmanagementsystemen, idealerweise davon 2 Jahre als Auditor
- Minimum of 5 years of experience in a quality systems related role, ideally 2 years as an auditor.
- Nachweisliche Erfahrung im Qualitätsbereich Pharmaverpackung
- Proven experience in the quality department of a pharmaceutical packaging company.
- Gute Kenntnisse der Anforderungen für Qualitätssicherungsinspektionen
- Good working knowledge of quality assurance inspection requirements.
- Gute Kenntnisse der cGMP, ICH, GAMPs, Annex 11 und Eudralex-Richtlinien
- Knowledge of cGMP, ICH, GAMPs, Annex 11 and Eudralex guidelines.
- Geschäftssicheres Deutsch und Englisch in Wort und Schrift
- Fluent in business German and English.
- Sehr gute Kommunikationsfähigkeit
- Very good communication skills.
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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.
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What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
