Job Description

POSITION RESPONSIBILITIES

  • Ensure highest Quality, Compliance and Safety standards are adhered to.
  • Lead and manage suppler changes assigned. Ensure that key stakeholders both internal & external are kept informed throughout the change control lifecycle process.
  • Conduct detailed technical assessments of materials and supplier changes from a Safety, Quality, Technical and Supply perspective and proactively manage the implementation of changes through the site change control process.
  • Provide ongoing input and support to the MRB team members, support continuous process improvement initiatives, share their technical knowledge and promote best practices.
  • Participate in problem solving teams as necessary.
  • Support the building and fostering relationships with internal and external stakeholder`s.

QUALIFICATIONS & EXPERIENCE

General

  • Minimum 3-4 years’ experience in a regulated manufacturing environment – ideally has worked in either a technical / validation / process engineering position
  • Demonstrated Technical knowledge in pharmaceutical or Biopharmaceutical operations (e.g. manufacturing, technology, engineering, quality)
  • Understanding of the change control process in a regulated manufacturing environment.

Technical/ Skills

  • Knowledge of material qualification and supplier change notifications.
  • Change management understanding and skills (i.e. Trackwise)
  • Knowledge of Quality Supplier systems (i.e. supplier Transparency system)
  • Project Management skills and the ability to lead a project.
  • Stakeholder management and management of multi decision makers in cross functional teams.
  • Demonstrated capability to deliver results RFT, in an FDA / HPRA Regulated production environment.
  • Demonstrated high level of problem solving and facilitation skills.
  • Working proactively and collaborating across multiple functional teams.
  • Experience dealing with external suppliers/ partners.

Education

  • Degree in a Science or Engineering discipline.
  • Lean Six Sigma qualification or experience in application of lean principles is desirable (but not essential).
  • Project Management qualification is desirable (but not essential).
  • Evidence of Continuous Professional Development is desirable

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