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
• 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 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

Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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