Pinewood Healthcare is a leading developer, manufacturer and marketer of healthcare products, currently employing over 300 people across two sites in Tipperary and Dublin. Originally established in 1976 to serve the renal care market in Ireland, Pinewood evolved over the years under indigenous Irish ownership until its sale in 2006 to the Wockhardt Group, an Indian global pharmaceutical and biotechnology company headquartered in Mumbai, India. Wockhardt employs over 7,000 people across 27 nationalities with a presence in the USA, UK, Ireland, Switzerland, France, Mexico, Russia and many other countries. It has manufacturing and research facilities in India, the USA and UK and a manufacturing facility in Ireland (Pinewood Healthcare).
The Quality Engineer - CSV is responsible for supporting the validation and lifecycle management of GxP computerised systems across the site, ensuring compliance with EU GMP Annex 11, GAMP 5, Data Integrity principles and internal Quality Management System requirements.
The role provides technical support for Computer System Validation activities throughout the system lifecycle, including validation planning, risk assessments, qualification testing, change control, periodic reviews and supplier documentation review.
Working closely with the Senior Software Quality Engineer, the successful candidate will support the delivery and continuous improvement of the site's Computer System Validation programme. The role will collaborate with Quality Assurance, Quality Control, Manufacturing,Production, Engineering, IT and external suppliers to ensure computerised systems remain compliant, validated and fit for their intended use throughout their operational lifecycle.
The successful candidate should possess a strong technical background, a good understanding of software systems and validation principles, and be capable of applying a risk-based approach to Computer System Validation in accordance with current regulatory expectations.
Responsibilities and Tasks:
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Support the validation and lifecycle management of GxP computerised systems.
- Prepare, review and execute Computer System Validation documentation.
- Develop and maintain validation documents including GxP Assessments, SCCA, URS, Risk Assessments, IQ, OQ, PQ, Validation Plans and Validation Summary Reports.
- Execute validation testing and document results.
- Perform risk assessments using a risk-based approach in accordance with GAMP 5.
- Support change controls, deviations, investigations and CAPAs related to computerised systems.
- Review supplier documentation and support supplier qualification activities.
- Support audit trail reviews, user access reviews and backup verification activities.
- Ensure compliance with EU GMP Annex 11, GAMP 5, Data Integrity principles and internal Quality Management System requirements.
- Work closely with Quality Assurance, Quality Control, Manufacturing, Engineering, IT and external suppliers on validation activities.
Education:
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Bachelor's degree in Computer Science, Software Engineering, Information Technology, Computer Engineering or another relevant engineering, scientific or Quality.
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Computer System Validation training or successful completion of a recognised Computer System Validation course.
Experience:
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Minimum 2 years' experience in Computer System Validation , Quality Assurance or a regulated pharmaceutical, biotechnology or medical device environment.
- Experience preparing and executing CSV documentation, including IQ, OQ and PQ protocols.
- Experience supporting the implementation and validation of GxP computerised systems.
Skills and Knowledge:
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Good understanding of Computer System Validation principles and the system lifecycle.
- Knowledge of GAMP 5, EU GMP Annex 11 and Data Integrity (ALCOA+) principles.
- Understanding of validation documentation, including URS, Risk Assessments, IQ, OQ, PQ and Validation Summary Reports.
- Strong technical skill with the ability to understand software systems and computerised system architecture.
- Knowledge of software development principles or programming would be an advantage.
- Good analytical, problem-solving and technical writing skills.
- Strong communication and organisational skills with the ability to work effectively in cross-functional teams.
