Quality Technician, Waterford

3 weeks ago

Waterford, Waterford, Ireland Q1 Scientific Ltd. Full time

The Quality Technician is responsible for verifying that quality is being maintained throughout the stability storage and sample management process.
Responsibilities
Specific responsibilities include, but are not limited to:
QMS:
Provision of assistance and advice to the Company on all QMS activities.
Ensure that all Q1 activities meet the quality standards specified by the Company QMS and in accordance with cGMP standards.
Continually monitors the QMS system suggesting improvements and CAPA measures.
Administration of quality manuals, continuous improvement initiatives & interaction with management personnel on quality initiatives.
Ensure all planned and unplanned changes (deviations) are adequately investigated and documented.
Audits:
Ensure compliance to GMP certification by conducting and reporting internal reviews.
Co-ordinates, prepares and is the lead for all internal, regulatory, supplier and customer audits.
Operational Activities:
Administration of quality documents, continuous improvement initiatives and interaction with management personnel on quality issues to include but not limited to:
Providing admin assistance to the Company on all QMS activities issuing controlled documents (logbooks, protocols for execution, etc.).
Maintenance of indexes
Issue of document numbers.
Review of completed documents for compliance to specification and to ensure all entries are complete.
Proposing/reviewing document changes as appropriate.
Performing daily checks on stability cabinets/room conditions as appropriate (in the absence of Operations).
Providing support as required for checking of samples on receipt at Q1 Scientific/on return to Client as appropriate.
Reviewing calibration and temperature mapping activities
This is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organisation and the overall business objectives of the organisation.
Qualifications/Skills
Education, Experience & Licensing Requirements
Primary degree preferable but not essential
Experience in working in a regulated environment
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