QA Manager (w/m)

CDD
Colmar
Posted 2 months ago

PPRS is an independent and fast-growing company, specialized in the development of innovative projects with diagnostic or therapeutic purposes in neurosciences.

Job Offer QA2021_02

Summary of Key Responsibilities :

  • Support the continued development and maintenance of the Quality Assurance document management systems
  • Manage documents through approval, issuance and archiving processes
  • Provide user support and training for document management systems
  • Track and close-out deviation and change control documentation
  • Conduct quality data reviews of GXP documents
  • Coordinate and conduct GXP Training and Maintain GXP training files
  • Conducts internal system/process audits to ensure compliance with company policies/procedures, if applicable
  • Coordinate external GXP audits and track audits through their lifecycle to closure
  • Develop, recommend and monitor corrective and preventive actions to ensure that quality issues are resolved and prevented in future through proactive and coordinated employee training and process innovation.
  • Research changes and updates to ICH, GXP regulations
  • Collaborate with cross-functional teams to facilitate the document review process
  • Author corporate Quality Systems policies and SOPs and support the continued development of the Quality Systems
  • Perform other QA functions as necessary to maintain quality oversight of ongoing activities and quality initiatives.

 

Qualifications:

  • At least Bachelor’s degree in a scientific discipline or biotechnology field
  • GCP certified
  • Strong pharmaceutical industry experience in Quality Assurance and document management.
  • Strong understanding of cGCPs, FDA, EMA and ICH regulatory standards/guidance documents. GMP and GLP experience is a plus. (Junior or Senior level according to experience in all the previous noted guidelines)

 

For any application, please contact recrutement@pprs-research.com

Apply Online

A valid email address is required.
A valid phone number is required.