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