1409-QC Compliance Specialist-Waterford Contractor

Purpose

The Quality Control projects team oversee the introduction of new equipment and lifecycle equipment management for example software updates. The team also lead and drive the delivery of ongoing QC continuous improvement initiatives.

Responsibilities

•Responsible for the generation of documentation – URS writing, GxP assessments, SOP’s/WI’s,
•Responsible for the review and approval of documentation IOQ, PQ, SOP etc,
•Responsible for upgrade and introduction of instruments in the QC laboratory, to ensure equipment is implemented on time to support product testing in meeting manufacturing & supply deliverables. The analytical instruments include (but 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 instrument’s 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
•Ensure all required training is completed on time

Qualifications

•One/two years’ experience in a similar compliance or projects role (preferable)
•Third level qualification (degree in science or related discipline) or appropriate relevant experience supplementing lower grade scientific qualification.
•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.