Connectivity Validation & QC Compliance Specialist

Tandem Project Management Ltd.; Waterford; On-site; EUR 48,000 - 70,000; Full time

Job summary

Tandem Project Management Ltd. in Waterford, Ireland is seeking a QC Connectivity Compliance Specialist to join our biopharmaceutical team.

The role blends quality control validation expertise with equipment connectivity and compliance system responsibilities to ensure robust regulatory compliance. You will review validation docs, coordinate quality records, manage deviations, and drive CCRs while collaborating with engineering, IT, and suppliers to execute multiple validation projects

Qualifications

• 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.

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.

Skills

Quality control

Validation

Documentation

Regulatory knowledge

Risk assessment

Change control

Deviation management

CSV principles

Connectivity systems

Cross-functional collaboration

Education

Relevant degree

Tools

Laboratory equipment

Connectivity hardware

Job description

Tandem Project Management Ltd. in Waterford, Ireland is seeking a QC Connectivity Compliance Specialist to join our biopharmaceutical team.

The role blends quality control validation expertise with equipment connectivity and compliance system responsibilities to ensure robust regulatory compliance. You will review validation docs, coordinate quality records, manage deviations, and drive CCRs while collaborating with engineering, IT, and suppliers to execute multiple validation projects