Quality Assurance Professional

Quality Assurance Professional

Halkorb RH, seeks on behalf of its customer, a leading pharmaceutical company, a Quality Assurance Professional.

Key responsibilities:

  • Ensure processes, products and business processes meet GMP, Novo Nordisk A/S and local requirements
  • Promote and ensure Quality Mindset and Behaviour within the different department of LMB area
  • Guarantee the product quality, patient safety and strive for simplicity

Missions :

1/- Ensure products and business processes meet GMP, NN and local quality standards Ensure products and business processes compliance and delivery :

  • Reception, reconciliation & QA review of Temperature traces drug product cold chain on time
  • Review of quality records
  • Close follow up on calibration, qualification & period system evaluation of processes
  • Review and approval of calibration certificates of devices/sensors used for temperatures/humidity control within the site
  • Ensure process compliance with internal and local requirements
  • Ensure product conformity, batch review (A11)
  • Follow up and investigation of CRs and deviations
  • Ensure compliance and review of product related SOPs and document

2/- Compliance of LMB Quality Management System :

  • Handling of Change Requests
  • Handling review of deviations
  • Yearly evaluation of critical GxP suppliers
  • Ensure compliance of LMB QMS
  • Ensure compliance and validated stat of facilities and equipment in LMB
  • GxP supplier evaluation and follow up
  • Ensure and maintain validated stat in LMB
  • Follow up on QA performance boards
  • Ensure QA support to other departments

3/- Quality Management review and QAP :

  • Take part to QMR preparation
  • Take part to QAP Establishment and follow up

4/- Document control & archiving process retention programme :

  • Handing Document control & administration of Quality Docs
  • Retention programme and archiving processes organization and management (LRM)
  • Handling and management of archiving facilities

5/- Audits, inspections and self-inspection :

  • Take part to Internal and external (health authorities) Audits and inspections
  • Execution and follow up on self-inspections
  • Ensure follow-up of internal & external audits and self-inspections
  • Take part to the audit of external suppliers

Profile :

  • Biologist, Chemist, Pharmacist Academic degree
  • 3 years of relevant experience working with establishment of Device/Pharmaceutical manufacturing and/or manufacturing Pharmaceutical products
  • In-depth knowledge of pharmaceutical quality and regulatory requirements
  • Business understanding of production of pharmaceutical products
  • Good knowledge on GMP Pharmaceutical Industry and on local requirement
  • Excellent command of written and spoken English. Spoken and written French skills are essential