A QC Compliance Specialist is required by CareerWise Recruitment for our Waterford based pharmaceutical company. This is a 23-month contract. This is a hybrid position you can work 3 days on site and 2 days from home. If you have experience in QC bench equipment connectivity, CSV validation and compliance then this is the position for you !!!
THE ROLE
Review and approve validation documentation including protocols, reports, risk assessments, and traceability matrices within pre-defined timelines
Coordinate the development of validation quality documents ensuring regulatory compliance
Document and manage deviations, non-conformances, and corrective actions with proper evaluation
Raise and coordinate Change Control Requests (CCRs) for project work, ensuring proper documentation and regulatory impact assessment
Ensure regulatory compliance with FDA, EMA, and company quality standards across all validation activities
Proven experience in validation and qualification activities within pharmaceutical or biotechnology industry
Hands-on experience in Quality Control operations and laboratory environments
Knowledge of QC bench equipment and connectivity systems
Robust regulatory knowledge of FDA, EMA guidelines related to validation and qualification
Proficiency in preparing validation documentation including protocols, reports, and compliance records
Experience with change control processes and deviation management
Knowledge of risk assessment methodologies and traceability requirements
Experience with connectivity compliance systems in pharmaceutical manufacturing Knowledge of computerized systems validation (CSV) principles
Familiarity with calibration management and metrology practices
Experience working with external suppliers and contractors
REQUIREMENTS:
Minimum 2-5 years of industry experience in QC validation and quality systems
Strong foundation in pharmaceutical/biotechnology quality control operations
QC bench equipment connectivity, validation, and compliance