QC Connectivity Compliance Specialist TPM6076

Summary:

A biopharmaceutical company in Waterford is seeking a QC Connectivity Compliance Specialist to join their team. This role combines quality control validation expertise with equipment maintenance responsibilities, specifically focused on QC bench equipment connectivity and compliance systems.

Responsibilities:

• 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.
• Collaborate with cross-functional teams including engineering, IT, and external suppliers for seamless validation execution.
• Identify process improvement opportunities in qualification and validation procedures.
• Contribute to continuous improvement initiatives within the QC connectivity compliance framework.
• Support project management of multiple validation projects simultaneously.

Qualifications & Experience:

• Relevant degree.
• Minimum 2-3 years of industry experience in QC validation and quality systems.
• Strong foundation in pharmaceutical/biotechnology quality control operations.
• 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.
• Strong 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 preferred.
• Knowledge of computerized systems validation (CSV) principles preferred.
• Familiarity with calibration management and metrology practices preferred.
• Experience working with external suppliers and contractors preferred.