Skip to main content

Quality Project Implementation and Process Engineer


Laura Schollen
Recruiter
+32 494 04 21 32


Job description

Goal: to ensure compliance and execution of the implementation of Projects within the company's Supply Chain.

  • Assure that compliant, aligned, lean and efficient quality processes, systems and tools are designed, deployed, implemented, monitored  and maintained in order to support the intended supply flows and logistical activities, from the initial phase of commissioning the site through to commercial activities and that compliance with cGMP and cGDP is ensured & maintained through ongoing training and process review and on-going monitoring of Key Performance Indicators (KPIs) and Key Quality Indicators (KQIs) as applicable.
  • Develop Quality-related procedures and Quality workflows for all Warehousing and Distribution activities to ensure Market Actions, Stop Distributions, Quarantine shipments, Returns, Damaged good handling, Destructions, Complaint Handling, Re-labeling & Repacking, Cold Chain storage and distribution are conducted in compliance with procedures at the LSP,
  • Ensure GMP & GDP critical documentation generated during assigned projects is properly prepared, managed and archived,
  • Develop and implement SOPs and job aids at the Logistic Service Provider meeting the requirements of the Quality Standards and in compliance with market regulations comply
  • Quality Systems: Support in the Design and deployment of compliant, robust, aligned, lean and efficient quality systems and tools at the LSP to support GMS and commercial strategy, and to support the product lifecycle and supply flow,
  • Ensure compliance of site validation activities to ensure compliance with industry regulations for validation activities which include but are not limited to manufacturing and lab equipment, utilities and facilities qualification, computerized system validation and QA IT tools implementation, process transfer and validation, analytical method validation.
  • Risk management: Designing and implementing a quality risk management process to help monitor and control systems and to identify and prioritize areas for continual improvement of process performance and product quality throughout the product lifecycle and supply flow
  • Operational excellence: Drive continuous improvement initiatives which positively impact the site Quality level and assure the use of operational excellences tools in quality procedures and processes,

Profile

  • Relevant advanced degree (Pharmaceutical or Biomedical Sciences or any other relevant scientific Masters degree)
  • Strong leadership, communication, decision making and problem solving skills
  • 10 years relevant experience in Pharmaceutical and/or Animal Health industry
  • Demonstrated success in project management 
  • Preferably experience with operational excellence tools
  • Experience of working in a cross functional team in a highly regulated environment
  • Experience with cold-chain storage activities 
  • Success in developing, implementing and maintaining Quality Systems and Standards within pharmaceutical logistics or manufacturing sites
  • Experience with site commissioning activities & validation of premises and computerized systems
  • Ability to manage multiple projects simultaneously and priorities work, goals and tasks in accordance with division and corporate objectives
  • Strong written and oral communication skills
  • Drives for Superior Results and Passion to Win 
  • Inspires Continuous Improvement and Breakthrough Thinking
  • Proficient in Dutch and English
  • Ability to travel on a frequent basis (Benelux)


Related vacancies

QA Specialist


Apply now for Quality Project Implementation and Process Engineer

Resume

Add resume

Related vacancies

QA Specialist