QA Validation

Dunboyne, Ireland | Posted on 05/14/2025

• Industry: Pharma/Biotech/Clinical Research
• Work Experience: 5+ years
• City: Dunboyne
• State/Province: Meath
• Country: Ireland

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients across more than 23 countries worldwide. Our services include cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing, and metrology services.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by offering a unique Employee Value Proposition, including the opportunity to work with talented professionals in the Pharma/Biotech industry. We provide permanent contracts, exposing employees to top pharmaceutical client sites in diverse cultural settings.

Employee Value Proposition

Employees are the "heartbeat" of PSC Biotech. We offer empowering career development through in-house training, mentorship, and ongoing guidance to facilitate career progression. We focus on creating high-performing teams that exceed client expectations in quality, budget, and timelines.

Overview:

The QAV / DDQ Specialist will oversee Digital Data Quality and Validation activities at the client facility. This role is a key part of the quality assurance team, ensuring operational compliance with cGMP regulations. The role requires maintaining cGMP standards in accordance with policies, procedures, and regulatory requirements, with experience within an FDA/EMEA regulated environment.

Key Accountabilities:

• Lead and participate in cross-functional teams to address compliance issues and achieve project milestones.
• Participate in investigations, risk assessments, and ensure timely implementation of actions.
• Contribute to all project phases, including design, procurement, construction, start-up, and validation.
• Review and approve Change Controls, Deviations, CAPAs, SOPs, and related documents for GMP compliance.
• Oversee qualification/validation, technical transfers, regulatory approvals, and operations.
• Review validation lifecycle documents and reports.
• Provide QA oversight of computer system validation activities following validation plans and GMP standards.
• Assess new regulatory guidance and industry best practices, updating systems accordingly.
• Assist in creating and maintaining QA policies, SOPs, and reports.
• Support continuous improvement initiatives.
• Participate in risk management activities and internal audits.
• Foster strong relationships with management and colleagues to promote a compliant culture.
• Escalate compliance risks promptly.
• Perform additional tasks as assigned by the Associate Director of QA Validation.

Educational and Experience Requirements:

• Postgraduate qualification in engineering or science (advantageous).
• Minimum 5 years' experience in Quality Assurance/Validation in the biological/pharmaceutical industry, including computer systems validation.
• Experience with commissioning and validation of computerized systems and process equipment.
• Knowledge of GAMP requirements is a plus.
• Experience supporting complex investigations and problem-solving.
• Project management skills with knowledge of Power BI.
• Experience with QRM, investigations, and problem-solving as a Quality SME.
• Strong communication skills.
• Logical thinking and proactive under pressure.
• Ability to work independently and in teams.
• Attention to detail in GMP documentation.
• Experience with quality management systems like VeevaVault, SAP, Trackwise, KNEAT.
• Knowledge of FDA, HPRA, EMEA regulations related to biologics and pharmaceuticals.
• Experience with regulatory agency interactions during inspections.