Job Type: Contract
Job ID: JO-1908-19256
Consultant: Karen McHugh
Do you have 4 years’ +experience in a Biotechnology/ Pharmaceutical/ GMP Environment
Do you have experience with experience with QMTS?
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.
Senior QC Associate- Change Controls - Dun Laoghaire - Dublin
Our Client is Amgen 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.
All activities within Amgen’s Quality System associated with QC Deviations, CAPA records, Analytical Results Assessments and Change Control.
Report writing for investigations.
Own and manage Change Controls through their life cycle for QC.
Lead, contribute to, oversee, run and participate in Root Cause Analysis, implementing improvements and Corrective Actions.
Trend analysis of Deviations relating to QC.
Ensure investigations constantly reflect current requirements and expectations.
Participate in cross functional teams with colleagues from other departments to assess, communicate and manage information and performance via scorecards and meetings.
Ensure timely completion of QC Deviations, CAPAs and Change Controls utilizing the appropriate procedures and Quality Management Tracking System (QMTS).
Ensure timely completion of each stage of the Analytical Results Assessments in line with the Quality Control Out of Specification and Unexpected Results procedure(s).
Ensure flow of communication to stakeholders.
Develop and maintain quality systems within QC to ensure ongoing compliance with cGLP.
Audit and Inspection preparation and participation.
Lead continuous improvement activities to achieve standards of operational excellence for Amgen.
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.
Apply expertise and critical thinking to independently resolve issues.
Provide technical guidance.
Be responsible for specific programs and/or projects.
Minimum 4 years’ experience in a Biotechnology/ Pharmaceutical/ GMP Environment.
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.
Ability to evaluate complex compliance issues.
Ability to work in a fast-paced environment with changing priorities.
Excellent Organisational Skills and Time Management.
Ability to work under minimal supervision.
Ability to identify and manage competing priorities.
Skills in the areas of teamwork, flexibility, coaching and motivating.
Hold a third level qualification in a Science related discipline.
Knowledge of lab operations, analytical lab techniques, commercialization, and cGMP.
Experience with Deviations and Laboratory investigations including CAPA identification and implementation.
Experience in leading Root Cause Analysis would be advantageous.
Experience in managing and owning Change Controls would be advantageous.
Excellent Hourly Rate
Minimum 12 month contract
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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