Technical Writer - Supply Chain - Dun Laoghaire - Dublin


Location: Ireland

Negotiable

Job Type: Perm

Industry: Biotech-Pharma-Medical-Device-Jobs

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 karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.

 

Technical Writer - Supply Chain - Dun Laoghaire - Dublin

 

Employer

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. 

 

Job Description

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


Requirements 

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


Package

Health plan for self & dependents

excellent pension plan

Annual performance related bonus

28 days annual leave

Share options

 

Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720

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