Job Type: Contract
Job ID: JO-2003-22552
Consultant: Karen McHugh
Are you a Senior QA specialist with experience sampling and testing of incoming raw materials/excipients and components?
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 QA Specialist - Raw Materiais - Amgen - Dublin
Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoighaire, South Dublin.
The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience on Ireland's leading aseptic manufacturing plant.
Contractors have a history of either extending their contract or being offered permanent positions on this site.
The Incoming Quality Assurance (IQA) Snr Associate will report to a QA Senior Manager and is a core member of the site Quality Assurance team.
The IQA Snr Associate will be responsible for sampling and testing of incoming raw materials/excipients and components.
The site is focused on continuous improvement of all work processes and practices, therefore in addition to routine Quality Assurance duties, IQA Snr Associates may be asked to carry out additional work functions to support site continuous improvement activities.
Perform Sampling of Incoming Raw Materials and Components in accordance with site procedure and ANSI standards
Clean room raw material Sampling required in accordance with procedural requirements
Proficiency in ANSI sampling of excipients, chemicals, primary and secondary packaging.
Inspect Raw Materials and Components in accordance with site procedures
Send Samples for Test to QC or Contract Laboratories in accordance with material Specifications
Compile, Review/approve incoming batch related documentation and associated documentation in preparation for disposition activities.
Perform all activities in compliance with Amgen safety standards and SOPs
Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
Provide Quality support for triage and investigation of non-conformances (NC’s)
Responsible for drafting NC’s and CAPA’s
Participates in customer complaint investigations as required.
Provides training and advice to staff in order for them to perform their desired functions.
Maintain the site reserve/retain samples program
Review and approve cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports, SOP, etc.) ensuring compliance with appropriate documentation
Support continuous improvement and Operational Excellence initiatives
Any other tasks/projects assigned as per manager’s request.
Based on the nature of this role candidates will need to have an eye test as part of the selection process, this will be coordinated the same time of any interview
University degree. Engineering or Science related discipline preferred.
Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and proven abilities in decision making
Strong organizational skills, including ability to follow assignments through to completion
Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations
Experience working in aseptic operations, protein formulation, vial and syringe filling.
Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
Operational Excellence experience
Hourly rate €45 - €55 per hour
Minimum 12 month contract
Karen McHugh is the consultant managing this position.
If you are a Senior QA Specialist interested in roles based in Dublin , you can contact Karen by e-mail email@example.com or phone +353-1-7978720 for a confidential chat.
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