I am seeking a dedicated Quality Assurance Specialist for Computer System Validation (CSV) to join the Quality Operations department. In this role, you will play a crucial part in maintaining the integrity of computerised systems and contributing to continuous improvement efforts.

As a Computer System Validation Specialist, you will support the life cycle management of computerised systems, ensuring compliance with regulatory requirements and actively participating in enhancing the CSV framework. Your responsibilities will include providing QA oversight on computerised system implementation projects, validating systems, reviewing and approving change controls, deviations, and CAPAs, and contributing to the improvement of IT Quality Management Systems.

Key Responsibilities:

• Collaborate with project teams to develop, plan, execute, and report on validation, test strategies, and data migration for computerised system implementation projects.
• Utilise your expertise in relevant regulations and computer validation methodologies to conduct CSV on various systems and programs.
• Support various departments by reviewing and approving change controls, deviations, and CAPAs related to computerised systems.
• Actively contribute to the continuous improvement of our IT Quality Management System.
• Escalate any data integrity or critical quality issues to the supervisor and Quality Management.

Job Requirements:

• Bachelor's degree in relevant fields.
• Minimum of 2 years of experience in the validation of computerised systems; knowledge of ERP system validation is desirable.
• Previous experience in writing, reviewing, and executing computer validation documentation; experience in other types of validation and temperature mapping is a plus.
• Minimum of 5 years' experience in working with quality systems and a regulated environment.
• Strong attention to detail and thoroughness, with a willingness to learn and adapt.
• Excellent communication skills, both written and verbal.
• Ability to work effectively within a team while also being capable of working independently.
• Proficiency in English is required.