Kenny-Whelan (A specialist division of the CPL group) are hiring a Technical specialist - Materials review to be based at our clients Biopharma facility in Brinny West Cork
Contact Jenn Dinan on 0860466583 and email jdinan@kenny-whelan.ie
JOB DESCRIPTION & SPECIFIC OBJECTIVES
This fixed term contract position representing the Vaccines IPT will provide expert technical support on the site Materials Review Board (MRB) team to support manufacturing and the business priorities of the Vaccines IPT. The Materials Review Board (MRB) team is part of the centralised Technical Operations Department on site.
The Technical Specialist will deliver on timely implementations of Supplier Change Notifications by conducting detailed technical assessments of the change, while working collaboratively with all internal departments and external partners, to meet the Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan
The successful candidate is accountable for the delivery of an effective and efficient MRB support to the Vaccines IPT.
The successful candidate will work in a dynamic environment.
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.
REPORTING STRUCTURE
Successful candidate will report to the MRB Site Lead.
QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS
General
- Minimum 4-5 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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All applications will be treated with the strictest of confidence
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Contact Jenn Dinan on 0860466583 and email jdinan@kenny-whelan.ie
