MES Quality Lead

Location Beerse
Discipline: Pharmaceutical
Contact name: Talitha van Romondt

Contact email: t.romondt@panda-int.com
Job ref: 20082
Published: 2 months ago
MES Quality Lead

For a leading pharmaceutical client in Beerse, Belgium we are looking for a MES Quality Lead. You will perform QA oversight for the MES (Manufacturing Execution Systems) relevant business processes supporting the QC Operations group as well as provide QA and compliance mentorship for Global MES initiatives and projects. The role is accountable to support the implementation and maintenance of the Q&C Vision in decision making process. The role is accountable to provide operational quality oversight for MES and ensures maintenance of the right level of compliance of MES platform business usage

Responsibilities:
  • Ensure quality and compliance is maintained in MES processes during execution and deployment.
  • Lead MES system’s deployment from a Quality Process perspective
  • Drive quality process standardization and harmonization within the MES framework
  • Escalate project issues to leadership to ensure areas of interdependency are appropriately accounted for and prioritized
  • Prepare and Lead MES system’s Quality Management Review meetings, CAPA and Change Control Boards
  • Improve MES system GxP processes between the sites by connecting the QA users across the different sites
  • Act as Quality approver for any global document linked to MES (Examples; MES incident management, MES Change Management). Act as Quality approver for any global Investigation, CAPA or Change Control related to MES systems.
  • Maintains MES system’s audit readiness. Support Periodic Review exercises led on MES systems.

Your Profile:
  • University/Bachelor’s degree in sciences (e.g., chemistry, biology, pharmacy, information technology, engineering). Master’s degree is preferred.
  • 10+ combined years of experience in Manufacturing, Quality Assurance, Quality Control, Validation or Engineering in vaccines/pharmaceutical industry.
  • Working experience within an FDA/EMA GMP (Pharmaceutical, Medical Devices) regulated environment is preferred. Familiarity with ISO requirements.
  • Working knowledge of Quality systems such as: Investigation/CAPA, Change Control, Document Management, Management Review process, etc. required.
  • Working experience in navigating and dealing effectively within a matrix organization, managing complexity, engaging, and collaborating with multi-disciplined teams across boundaries and influencing without line authority, including remote team members.
  • Project Management skills and experiences. Knowledge of Project methodologies and process excellence.

Practicalities:
  • Location: Beerse, Belgium
  • ASAP needed
  • Minimum 1 year contract
  • Full time On/Off Site (remote is possible)

Interested? apply with your CV at t.romondt@panda-int.com or call at +31 (0)20 2044 502.