8 days ago on aristo-group.com

QA Manager (m/w)

Aristo Group

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QA Manager (m/w)

Für unseren Kunden suchen wir eine(n)

QA Manager (m/w)

Referenznummer:3872Einsatzort:BaselBeschäftigungsform:FreiberuflichBeginn des Projekts:Ab sofortAuslastung:6 Monate ++ Ihre Aufgaben:
  • Interface directly with contract manufacturers and alliance partners to manage quality related issues
  • Interact with key stakeholders such as Product Development, Supply Chain and Logistics, and Regulatory Affairs to ensure that clinical drug products are manufactured in accordance with established procedures, cGMPs, and appropriate regulations
  • Provide excellent customer service to key stakeholders by ensuring on time review and release of clinical products, fostering clear, open communication and providing expert consulting on GMP related questions and concerns
  • Review and approve clinical manufacturing, packaging, and labeling drug product batch records, in-process quality control data, change controls, deviations, and test results for timely disposition of drug substance/drug products intended for human clinical use
  • May serve as QA lead in complex quality investigations/deviations/clinical compliant investigations
  • Develops, implements, and maintains systems, programs and processes to ensure compliance with Current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs), along with compliance of protocols, GMPs and safety regulations
  • Creates, implements, and qualifies current and new programs, policies, processes, procedures and controls to ensure that performance and quality of products conform to established standards and agency guidelines
  • Serves as a lead/ coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products
  • Interfaces with contract manufacturers to address and resolve more complex product/process performance issues
 Ihre Qualifikationen:
  • BS in Biological Sciences, Bioengineering or Chemistry; MS a plus
  • 10+ years of experience in the biotechnology or pharma industry with a primary focus on quality assurance activities
  • In-depth knowledge of Quality Systems, and worldwide cGMP standards and requirements for manufacturing and distribution of clinical supplies
  • In-depth knowledge of QA principles, concepts, industry practices, and standards
  • Experience in reviewing/approving of QC release testing and characterization of small molecule and medical device products

Wir freuen uns auf Ihre Bewerbung:
Aristo AG
Alexander Gehring
T: +41 41 508 79 00
E: a.gehring@aristo-group.ch

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