Beschreibung
Aktuell möchten wir für unseren Kunden, ein renommiertes Unternehmen der Pharmazie, die Vakanz „Quality Assurance Manager (m/w/d)" besetzten.Tätigkeiten:
- Maintenance and improvement of the local GMP/GDP Quality Management System regarding commercial and investigational medicinal products to ensure continuous compliance with regulatory and corporate requirements
- General coordination of local SOP review
- Administration and improvement of the local training system and documentation
- Support of the Qualified Person
- QM responsibilities
- Coordinate overall SOP training assignments in the electronic training system with the functional areas and global quality management and maintain the local training curriculum. Act as Training representative for ONPG.
- Coordinate review and approval of local SOPs with the functional areas and global quality management in the electronic document management system
- Creation and revision of GMP/GDP relevant SOPs
- Quality Review of batch documentation and document preparation for product releases by the Qualified Person
- participate in the risk assessment for external service provider
- Perform quality management introduction trainings.
- Perform monthly quality system reviews and participate in annual management reviews and product quality reviews
- Act in TrackWise for the assigned quality records (deviations, complaints, change controls, CAPAs and action items).
- Additional responsibilities regarding product serialisation
- Managing all aspects related to serialization i.e. supporting Artwork implementation, updating and uploading Master data to EU-Hub via a service provider 'TraceLink', organizing the relevant NMVO contracts, and handling of alerts
- Quality Admin role within Tracelink
Ihre Expertise:
- Experience in Quality Assurance and Good Manufacturing Practices (GMP)
- Knowledge/experience in relevant regulations and guidance documents (AMG, AMWHV, EU-GMP/GDP, EU FMD)
- Very good communication skills in English (written and oral)
- Open minded, good problem solving and resolution skills
- Well versed with MS Office, Excel and PowerPoint
Weitere Details:
- Start so bald wie möglich
- 12 Monate zunächst befristet
- Vollzeit; Überstunden werden vergütet
- 100% remote
- 30 Tage Urlaub im Jahr
Haben wir Ihr Interesse geweckt?
Dann bewerben Sie sich jetzt online oder per E-Mail (v.valanzano[at]progressive.de) mit Ihrem aktuellen Lebenslauf und Ihrer Gehaltsvorstellung - ein Anschreiben wird nicht benötigt.
Ich freue mich auf Ihre Bewerbung.
Dieser Geschäftszweig der SThree GmbH betreut die ausgeschriebene Stelle im Auftrag ihres Kunden.