Quality Engineer – Computer System Validation

About Pinewood Healthcare

Pinewood Healthcare is a prominent developer, manufacturer, and marketer of healthcare products with over 300 employees spread across its Tipperary and Dublin locations. Founded in 1976 to serve Ireland's renal care sector, it evolved under Irish ownership until its acquisition in 2006 by the Wockhardt Group, a multinational pharmaceutical and biotechnology company based in Mumbai, India. Wockhardt operates globally with more than 7,000 personnel across 27 nationalities and maintains manufacturing and research facilities in India, the USA, UK, and Ireland.

Role Overview

The Quality Engineer specializing in Computer System Validation (CSV) will support the validation and lifecycle oversight of GxP computerized systems within the facility. Ensuring adherence to EU GMP Annex 11, GAMP 5 guidelines, Data Integrity standards, and internal Quality Management System protocols is pivotal to this role.

Key Responsibilities

• Assist with the validation and ongoing management of GxP computerized systems.
• Create, review, and implement Computer System Validation documentation.
• Develop and maintain validation documentation including GxP assessments, SCCA, URS, risk assessments, IQ, OQ, PQ, validation plans, and summary reports.
• Carry out validation testing and accurately document outcomes.
• Conduct risk assessments applying a risk-based strategy aligned with GAMP 5.
• Support change control processes, deviations, investigations, and CAPAs related to computerized systems.
• Review supplier documentation and aid supplier qualification processes.
• Assist with audit trail reviews, user access assessments, and backups verification.
• Collaborate closely with Quality Assurance, Quality Control, Manufacturing, Production, Engineering, IT, and external suppliers to maintain system compliance and validity.

Required Education & Training

• Bachelor’s degree in Computer Science, Software Engineering, Information Technology, Computer Engineering, or relevant engineering, scientific, or quality-related discipline.
• Completion of recognised training or course in Computer System Validation.

Experience Needed

• At least two years' experience in Computer System Validation, Quality Assurance, or within a regulated pharmaceutical, biotechnology, or medical device environment.
• Proficient in preparing and executing CSV documentation such as IQ, OQ, and PQ protocols.
• Hands-on experience supporting implementation and validation of GxP computerized systems.

Skills & Knowledge

• In-depth understanding of Computer System Validation principles and system lifecycle management.
• Familiarity with GAMP 5, EU GMP Annex 11, and Data Integrity (ALCOA+) requirements.
• Comprehensive knowledge of validation documents like URS, risk assessments, IQ, OQ, PQ, and validation summaries.
• Strong technical aptitude to comprehend software systems and computerized system architecture.
• Advantageous to have knowledge of software development concepts or programming skills.
• Excellent analytical, problem-solving, and technical writing capabilities.
• Effective communication and organizational skills, with the ability to collaborate efficiently within cross-functional teams.