Supplier Quality Engineer

Location Leiden, Gemeente Leiden, South Holland
Discipline: Pharmaceutical
Contact name: Sayf Idais

Contact email: s.idais@panda-int.com
Job ref: 13492
Published: 2 months ago

For one of the biggest leading pharmaceutical companies worldwide, we are looking for a Supplier Quality Engineer. You will have a lot of interaction with the procurement department (supplier, budget control, ad hoc escalation, supplier issues, non-conformance, supplier performance, reports every quarter, preparing date, assessment of suppliers) and managing the engagement with the team management in the US and NL. The job offers a 12-month contract with extension. The company is in Leiden.

Responsibilities:

  • Provide timely business support for the assigned CSS Supplier Quality Management (SQM) function globally.
  • Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
  • Lead the deployment of the SQM strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain.
  • Actively leverage talents and lead teams (SQEs and others).
  • Collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers’ quality and overall service and performance.
  • Proactively identifies, develops, and leads the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analyses/improvements, DOE/process optimization, and other technical or Process Excellence (PEx) tools in support of supplier-related changes, risk management, product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.

 

Requirements:

  • A minimum of a bachelor’s degree in Engineering, an Applied Science or a related technical and quality field is required.
  • A minimum of 6+ years of experience in Quality Engineering or Quality Assurance, including data analysis, risk assessment and risk mitigation is required.
  • Prior manufacturing, plant or technical background is required.
  • Working experience in GMP regulated environment (Medical device, pharmaceutical, etc.).
  • Demonstrated knowledge of manufacturing principles and practices, and procedures.
  • Direct experience in plant and/or supplier GMP auditing is preferred.
  • Broad experience with quality systems, including but not limited to validation, nonconformance, CAPA systems and investigations, laboratory controls, production and process controls, is required.
  • Experience with documentation and technical writing skills, in a regulated compliance
  • environment, is required.
  • Component Qualification/Process Validation experience is preferred. New product
  • introduction experience is desired.
  • Prior experience with FDA inspections is desirable.
  • Broad knowledge of Quality System Regulations and Supplier Quality Management principles are desired.
  • Demonstrated ability to identify compliance risks and assess business impact, is required.
  • English is a must have, Dutch is a nice to have.
  • Able to work 1-2 days on site.

 

Project start date:

Short notice preferred
 

Project duration:

12 months
 

Interested?

If you are interested in the above description, please apply with your CV and a letter of motivation.

 

PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?

 

For further information, please contact Sayf Idais at +31 (0)20 20 44 502 or by email at s.idais@panda-int.com