Quality Control Compliance Specialist

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 lead and drive the delivery of ongoing QC continuous improvement initiatives.

Core Duties and 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.

Education & Qualifications Required:

• Third level qualification (degree in science or related discipline) or appropriate relevant experience supplementing lower grade scientific qualification.
• One/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.

Please note, we do not require agency assistance with this role.