QA project support

Firma: XDES
Jobbtype: Full-time
XDES is specialist in recruitment van technisch ;

Job Description
As Quality Assurance we take a stand to consistently ensure the delivery of safe, cost effective and high-quality products for the patients in need. The QA department has an OCP (Operational Commercial Products) and an NPD (New Product Development) & Launch branch. This position will be placed within the OCP group. QA OCP provides end-to-end Quality support ( non-conformance management, CAPA, change control, validation and batch disposition) for commercial products.In addition to the base business activities for our commercial products, the company also has a large project portfolio to improve on our processes, implement new technologies, perform ELM and increase our capacity to be able to deliver future demands.We are looking for a contractor to support these portfolio projects. In the projects you will typically be a core or extended team member with the responsibility to assure project changes are implemented according to cGMP guidelines and quality management systems.The activities include, but are not limited to:
  • The QA contractor acts as a quality expert and applies our Quality Systems to create, review and approve GMP documentation. The contractor works in close collaboration with other departments (Operations, QC, Engineering, RA, etc.);
  • Review and approve change controls, validation protocols and reports, validation assessments, URS, and appliable lifecycle documentation;
  • Track and monitor progress of changes to anticipate, flag and prevent any delays in change implementation.

Job Requirements
  • BSc/HBO (or equivalent) in bioscience, chemistry, pharmacy or equivalent;
  • Some years of QA experience in pharmaceutical or related industry (nice to have);
  • Up to date knowledge of current GMP regulations (must have);
  • Experience in Change control and all documenting related activities (must have);
  • Experience with documentation systems like Trackwise, True Vault (nice to have);
  • Experience with Systems like Delta-V, Scada, PAI or MES (must have);
  • Experience in Computer system validation (Delta V, VMS) (nice to have);
  • System Validation experience (nice to have);
  • Good communicative and advisory skills in both Dutch and English (must have), both (verbal and written);
  • Able to work independently as well as in a team;
  • Ownership, team player on project level.

Salary and Benefits
This is a responsible job with good employment conditions.

Contact Us
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer of via e-mail: Kenmerk: 10703.
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