- 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
- 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.
- 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.
- 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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