Almirall ist ein internationales Pharmaunternehmen mit Sitz in Barcelona. Die Almirall Hermal GmbH entwickelt Dermatika bis zur Marktreife und ist damit führend in Europa und Marktführer in Deutschland. Das Unternehmen produziert und vermarktet Arzneimittel aus den Bereichen Dermatologie und Neurologie. Qualifizierte und engagierte Mitarbeiterinnen und Mitarbeiter bilden die Basis unseres Erfolgs.
Mission
The department QA/Quality Assurance of Almirall Hermal GmbH (Reinbek, DE) is seeking - as soon as possible - a “QA Manager / Qualified Person” (f/m/d).
Tasks and Responsibilities
Initially this position is foreseen to cover the following tasks (“QA Manager Delta Project”):
- Supporting the Delta QA project activities (product transfers from / to Reinbek site) at local level and coordinate with corporate and local functions
- Collect relevant product transfer information and compile into reports
- Coordinate and execute implementation of starting materials and bulk / finished products at the site
- Gain product knowledge related to the new products
- QA review / approval of related equipment qualifications
- Securing of GMP-compliant documentation
With the completion of the related Delta QA tasks the position is foreseen to be converted into a “QA-Manager / Qualified Person” role:
- Acting as Qualified Person (AMG §14/15, Directive 2001/83/EC) and QA Manager with product related tasks
- Responsibility for the GMP-compliant production, testing and release of medicinal products acc. to medicinal product regulations
- Release (batch certification / confirmation) and rejection of medicinal products acc. to medicinal product regulations
- Classification of product related deviations and results in the frame of batch release
- Classification of product quality related complaints and their follow up
- Review / approval of specifications and test procedures
- Review / approval of product dossiers, technical files, PIFs
- Coordination / execution of product related compliance tasks (such as SAP workflow approvals, MBR review / approval, LIMS approvals, OOS handling / classification, stability report review / approval)
- Cooperation in the field of support and development of the site´s quality systems
- Securing of the cooperation with relevant internal departments, incl. corporate functions, other Almirall sites and CMOs
- Participation in GMP-audits internally, at suppliers / CMOs
- Fulfilling the above listed tasks not only for medicinal products but also for medical devices, cosmetics and food supplement
Qualification
- Master degree in life sciences (preferably Pharmacy or comparable)
- Proven qualification and acceptance as Qualified Person
Special knowledge
- Detailed knowledge and experience in pharmaceutical legislation, esp. GMP, pharmaceutical analytics and production
- Very good English and German language skills verbally and in writing
- High level of quality and responsibility awareness
- Good team and communication skills
Experience
- Several years of professional experience in the pharmaceutical industry in the areas of quality assurance, pharmaceutical analytics / production
- Solid knowledge of GMP, GDP and preferably experience in medical devices and cosmetics
- Substantial experience in quality assurance process management
Other
- Full time work capacity
- Willingness for frequent business trips
- If you are interested in this job opportunity please apply via gHRow. For questions related to this position please contact Kai Grüning.
Als attraktiver Arbeitgeber bieten wir Ihnen leistungsorientierte Bezüge mit guten sozialen Leistungen, die persönliche Atmosphäre eines mittelständischen Unternehmens, eingebunden in einen internationalen Pharmakonzern, und hohes Ansehen im Markt. Interessiert? Dann freuen wir uns auf Ihre Bewerbung mit Angabe Ihres frühestmöglichen Eintrittstermins und Ihrer Gehaltsvorstellung.