Description Overview

Scope of the Role

• Represent QA in computer system validation projects including change controls, deviations and periodic reviews and Data integrity for CSCI
• Provide support with guidelines and regulations such as GAMP 5, EU GMP Annex 11, and FDA CFR Part 11
• Act according to the Quality Assurance (QA) vision, strategy and standards for the integrated Perrigo CSCI group
• Keep going awareness of new and developing regulations (different ISO regulations, GMP, GDP, MDR, MDD)
• Support in the maintenance of Quality Systems, including electronical systems (Trackwise, LMS,…)
• Provide QA training to the entire group (European branch of the Perrigo Company) regarding computer system validation and Data Integrity and evaluate training effectiveness, including the creation of powerpoint presentations, online recorded trainings, etc.
• Ensure adherence to critical procedures and compliance to requirements for record retention
• Be part of third-party qualification and regular third-party auditing for all topics related to Computer System Validation and Data integrity
• Assist in performing internal QA audits
• Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions. related to Computer Systems and Data Integrity
• Provide support in establishing and maintaining the ISO 9001 and ISO 13485 Quality Management System related to Computer Systems and Data Integrity
• Identify gaps and areas for improvement in QA processes related to Computer system and handling and lead remedial actions and initiatives

Experience Required

• Bachelor degree in IT, engineering, biochemistry, chemistry or equivalent through experience.
• You are fluent in spoken and written English, other languages are a benefit.
• At least 2-5 years relevant experience in Computer system validation in Pharmaceutical and/or Medical Devices industry
• Deep knowledge of FDA regulations (especially CFR Part 11), EU GMP Annex 11 and GAMP 5.
• Knowledge of the relevant European regulations for pharmaceutical products (GMP specifically Annex 11, GDP), Medical Devices (MDR, MDD, ISO13485, ISO14971), Food, Food Supplements (HACCP, ISO 22000); Cosmetics (ISO 22716) is an asset

• Perrigo offers you a challenging position within a strong and dynamic company
• A professional environment offering you the opportunity to boost your career through training, coaching & support, learning on the job
• A competitive compensations and benefits package for the required level and experience
• The opportunity to work in a hybrid working model as part of our selfcare and wellbeing strategy