Job Type: Perm
Job ID: JO-1908-19261
Consultant: Karen McHugh
Do you have experience with Deviations, CAPAs, Change Controls and audits?
Do you have a minimum of 5 years' experience in pharmaceutical/healthcare?
If you have the relevant experience, please forward your CV to firstname.lastname@example.org for review or call 353 1 7978720 to discuss in confidence.
Technical Writer - Supply Chain - Dun Laoghaire - Dublin
Our Client and the role will be based in their Dun Laoghaire plant.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
The role will provide technical expertise with a focus on Compliance, Continuous Improvement while implementing a Lean Culture and Right First Time (RFT). The role also represents the Supply Chain unit by liaising with internal and external customers. The role may involve carrying out additional work functions that are not described in this specification but are associated with the role.
Primary responsibilities include managing the Supply Chain aspect of the Deviation, Investigations and Change Control process to ensure requirements are met and issues are addressed, and a cycle of continuous improvement is in place.
Specific Duties/ Scope:
All activities within Amgen’s Quality System associated with Supply Chain Deviations, CAPA records and Change Controls
Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions
Develop, review and update Supply Chain Standard Operating Procedures
Develop protocols for execution in Supply Chain in support of change controls, non-conformances & troubleshooting investigations with support from relevant SMEs
Trend analysis of Deviations relating to Supply Chain
Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings
Perform tasks and participate on project teams assigned to assist in the timely completion of activities associated with the attainment of group, departmental, team and corporate goals
Ensure timely completion of Supply Chain Deviations, CAPAs and change controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS)
Provide technical guidance
Ensure flow of communication to stakeholders
Apply expertise and critical thinking to independently resolve issues
Be responsible for specific programs and/or projects
Participate in Regulatory Inspections
Apply analytical thinking to evaluate and interpret complex situations/problems using multiple sources of information
Anticipate and prevent potential problems
Excellent verbal and written communication skills including technical writing, presentation and facilitation skills
Strong ability to lead teams and effectively utilize team resources
Experience in interacting with regulatory agencies including written responses
Experience with Deviations, CAPAs, Change Controls and audits
Ability to evaluate complex compliance issues
Ability to work in a fast-paced environment with changing priorities
Work under minimal direction Knowledge and Experience
Hold a third level qualification in science related discipline
Have a minimum of 5 years' experience in pharmaceutical/healthcare
Possess key competencies to include planning/organization, problem solving, communication, teamwork, flexibility, coaching and motivating
Advanced experience and capability with MS Office applications
Health plan for self & dependents
excellent pension plan
Annual performance related bonus
28 days annual leave
Karen McHugh is the consultant managing this position.
If you have any queries about this role, you can contact him by e-mail email@example.com or phone +353-1-7978720
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