Pharmacist - Lifecycle Management (m/w/d) - Greenfield, United States - Nexus Dynamics

Nexus Dynamics
Nexus Dynamics
Verified Company
Greenfield, United States

4 weeks ago

Meredith Sinclair

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Meredith Sinclair

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Description

The Luye Pharma AG in Miesbach has been a partner of the pharmaceutical industry worldwide since 1997. We are developers and manufacturers of innovative transdermal dosage forms (medicated patches) of proven and highly effective drugs for international markets. As part of Luye Pharma, we also develop the European business of this dynamically growing and demanding pharmaceutical company, which currently employs over 4,000 employees worldwide.

Validation Expert Lifecycle / Lifecycle Manager (m⁠/⁠w⁠/⁠d)

Your responsibilities
  • As a Validation Expert Lifecycle, you are responsible for the validity of a commercially manufactured product (transdermal patch) throughout its product lifecycle at the Miesbach site. You coordinate technical issues and projects, make decisions, set timelines and responsibilities, and ensure their compliance.
  • You act as a subject matter expert (m⁠/⁠w⁠/⁠d) in terms of lifecycle management for all products throughout their entire product lifecycle. This also includes presenting during inspections and customer audits.
  • You manage process knowledge and process improvement projects for all commercially manufactured products at the site throughout their entire product lifecycle.
  • You initiate and manage improvement projects (quality, effectiveness) based on the data listed in the team.
  • You handle troubleshooting, create root cause analyses for complex deviations, define CAPAs (Corrective and Preventive Actions
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