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