QA Validation

Dunboyne, Ireland | Posted on 05/16/2025

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

Job Description

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, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services.

'Take your Career to a new Level'

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points, offering the opportunity to work with talented professionals in the Pharma/Biotech Industry. We provide permanent contracts with exposure 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 guidance to facilitate career progression. We aim to create high-performing teams that exceed client expectations in quality, stay within budget, and meet deadlines.

Overview:

The QAV / DDQ Specialist will oversee Digital Data Quality and Validation activities at the client facility, ensuring operational compliance with cGMP regulations. The role involves maintaining cGMP standards, in line with policies, procedures, and all relevant regulations. The candidate must meet educational and experience requirements within an FDA/EMEA regulated environment.

Requirements

Key Accountabilities:

- Lead and participate in cross-functional teams to address compliance issues and achieve project milestones.
- Participate in investigations and risk assessments related to deviations, complaints, and changes, ensuring timely actions.
- Contribute to all project phases, from design to system release.
- Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documentation for GMP compliance.
- Oversee qualification/validation, technical transfers, regulatory approvals, and operations.
- Review validation lifecycle documents and reports.
- Supervise computer system validation activities following good automation practices and validation plans.
- Evaluate new regulatory guidance and industry best practices, updating quality 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.
- Take on additional tasks as directed by the QA Validation leadership.

Educational and Experience Requirements:

- Postgraduate qualification in engineering or science (advantageous).
- Minimum 5 years' experience in Quality Assurance/Validation within the biological/pharmaceutical industry, including computer systems validation.
- Experience with commissioning and qualification of computerized systems and process equipment.
- Knowledge of GAMP requirements is a plus.
- Experience supporting investigations and problem-solving techniques.
- Project management skills with knowledge of Power BI.
- Experience in 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/pharmaceuticals.
- Experience with regulatory agency interactions during inspections.

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