Pharmacist - Qualified Person, Evaluation (m/f/d) - Medina, United States - Skyline Solutions

Skyline Solutions
Skyline Solutions
Verified Company
Medina, United States

3 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 people worldwide.

Pharmacist as QP Trainee or Qualified Person (m⁠/⁠w⁠/⁠d)

Your tasks
  • Depending on your qualifications, you will assume the role of Qualified Person based on §15 and §19 of the German Medicines Act (AMG), in particular making decisions on the use of marketable products and clinical trial preparations
  • Evaluation of quality incidents and processing resulting measures such as notifying authorities and implementing market actions
  • Evaluation and implementation of legal/regulatory requirements
  • Accompaniment of authority inspections, customer audits and self-inspections, as well as auditing of suppliers and service providers
  • Participation in the processing, investigation and evaluation of OOS, deviation and change control procedures, pharmaceutical quality complaints and CAPAs
  • Participation in the review and approval of process validations, PQRs, manufacturing and packaging instructions
  • Participation in training
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