Role Purpose:
* A new vacancy has arisen for a Quality Control Compliance Specialist to join our client’s Quality Control Projects Team at their busy biopharmaceutical facility in Co. Waterford.
* The Quality Control projects team oversee the introduction of new equipment and lifecycle equipment management, for example, software updates.
* The team also leads and drives the delivery of ongoing QC continuous improvement initiatives.
Core Duties and Responsibilities:
* Responsible for the generation of documentation – URS writing, GxP assessments, SOPs/WIs.
* Responsible for the review and approval of documentation IOQ, PQ, SOP, etc.
* Responsible for the upgrade and introduction of instruments in the QC laboratory, ensuring equipment is implemented on time to support product testing in meeting manufacturing & supply deliverables.
* The analytical instruments include (but are not limited to) UPLC, HPLC, Biacore, CE, Microscope, Balance, O2 Headspace, Karl Fischer, TOC, and Plate readers.
* Participate in Change Control Request facilitation and management in relation to QC instruments' introduction.
* Overall responsible for the introduction of instruments for the QC laboratory.
* Work closely with the Project Manager to ensure adherence to project timelines and critical milestones are met during new instruments introduction.
* Work closely with Validation, QA, IT, Metrology, QC Analyst, SME, and DI team for qualification & validation strategy alignment, timely completion of the GxP assessment, User Requirement Specification, IOQ protocol pre-approvals, and associated documentation.
* Conduct duties in a safe manner and report all safety issues or concerns.
Education & Qualifications Required:
* Third level qualification (degree in science or related discipline) or appropriate relevant experience supplementing lower grade scientific qualification.
* One to two years’ experience in a similar compliance or projects role (preferable).
* Excellent communication skills (interpersonal, presentation & writing).
* Works well with others at all levels of the organization, across multi-sites, and in a multi-national environment.
Initiative: Able to work in a self-directed manner to see issues through to completion.
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