A QC Compliance Specialist is required by our pharmaceutical client in Waterford.
Job Description
This is a 12-month contract position responsible for introducing new quality control laboratory equipment.
Key Responsibilities:
* Generate documentation including User Requirements Specifications (URS), GxP assessments, Standard Operating Procedures (SOPs)/Work Instructions (WIs).
* Review and approve documentation such as Instrument Qualification (IOQ) protocols, Performance Qualifications (PQ), SOPs, etc.
* Upgrade and introduce analytical instruments in the QC laboratory to ensure timely implementation supporting product testing in meeting manufacturing and supply deliverables.
The analytical instruments include but are not limited to:
* Ultra-Performance Liquid Chromatography (UPLC)
* High-Performance Liquid Chromatography (HPLC)
* Biacore
* Capillary Electrophoresis (CE)
* Microscope
* Balance
* O2 Headspace
* Karl Fischer
* Total Organic Carbon (TOC)
* Plate readers
Collaboration and Communication:
Participate in Change Control Request facilitation and management related to QC instrument introductions.
Work closely with the Project Manager to ensure adherence to project timelines and critical milestones during new instrument introduction.
Collaborate with Validation, Quality Assurance (QA), IT, Metrology, QC Analyst, Subject Matter Experts (SME), and Data Integrity teams for qualification and validation strategy alignment.
Requirements:
To be successful in this role, you will have:
* A third-level qualification in science or a related discipline, or equivalent relevant experience.
* One to two years of experience in a similar compliance or projects role, preferably.
* Excellent communication skills, including interpersonal, presentation, and writing abilities.
* Ability to work independently and collaboratively at all levels of the organization, across multiple sites, and in a multinational environment.