A Quality Control Analyst required by CareerWise Recruitment for our Waterford based pharmaceutical client. This is a 12-month contracting position. You would can to be based 3 days on site and 2 days remotely.
THE ROLE:
* You will be Responsible for isolating particles from sterile biologics and informing the investigation as to the origin on the particle. Specifically, FTIR, scanning electron microscopy, RAMAN spectroscopy
* Provide analytical chemistry services and support to Site.
* Effective interaction with other departments on matters related to raw materials, intermediates and finished batch In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
* Maintain, update and issue chemical methods, specifications and SOP's in compliance to pharmacopoeial and regulatory
* Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP's and updates.
* Trend such results, record on COA's where required and complete OOS's investigations on a timely basis.
* Update the QC Team Leader on potential problems and highlight improvements where possible by use of the normal communication means.
* Ensure all quality documentation and records are complete and current
* Ensure QC laboratories meet current Good Laboratory Practice (cGLP) requirements.
* Ensure relevant procedures are correctly defined and followed
* Ensure that critical chemical testing and related equipment meets current validation requirements (IQ, OQ, PQ) where
* Audit and review chemistry test results on a daily basis and ensure compliance with cGLP.
* Checking/auditing laboratory notebooks and analytical reports
REQUIREMENTS:
* 4years' experience in the Medical Device Industry.
* Minimum of a primary degree in an Engineering or Technical Discipline
* Experience in Process characterization, Validation and statistical methods.
* Meticulous attention to detail with a methodical and analytical approach to problem solving.
* You would can to be based 3 days on site and 2 days remotely.
Please call Louise Mulligan today for further information on or email:
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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