Senior QA Specialist - Raw Materiais - Dublin


Location: Ireland

EUR 45 - 55 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

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


Senior QA Specialist - Raw Materiais - Amgen - Dublin


Job Description

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.


Requirements

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


Package

Hourly rate €45 - €55 per hour

Minimum 12 month contract


Contact

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 karen@jobcontax.com or phone +353-1-7978720 for a confidential chat.

JobContax do not send CVs to clients without candidate permission.

With over 50 years of technical recruitment experience, JobContax is the leading recruiter of QA Specialists in Dublin and Ireland.

Due to the large volume of applications, JobContax may not be able to respond to every individual.


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