QA Specialist - Meath - URGENT - 6 month contract

Quality Assurance Specialist Co. Meath Hybrid 6 month Contract A start up tech company in the pharmaceutical industry has created a new role for a QA Specialist with experience in GMP.This is an exciting and innovative role with a small team of individuals with a great culture. Company values are diversity, integrity and respect within the workplace. We believe that diverse perspectives and backgrounds foster innovation and drive growth. Role : We are seeking an experienced Quality Assurance Specialist who will contribute to strengthening our Quality Management System and company. The Quality Assurance Specialist will work hand-in hand with our Development Operations Teams, QA Testers, and other stakeholders to deliver a timely, high-quality compliant SAAS product. Who will love this job? We believe that this job is for someone who -will take the chance and make an individual impact through autonomy and responsibility -is a self-motivated, multi-tasker, proven team player within cross functional teams -thrives in a start-up environment and can contribute to original ideas -is good at rolling up their sleeves to achieve results in a start-up environment -enjoys Critical thinking / evaluation of process problems skills -who has strong work ethic and the ability to work independently The ideal candidate should enjoy improving how things are done, as well as making sure they get done Responsibilities :

• Collaboration with the Head of Quality Assurance and other Department Managers to enhance internal compliance, through continuous improvement
• Supporting the set up and shaping of our Quality Management Systems
• Preparing for our ISO 9001-2015 Certification and maintaining compliance within the ISO 9001 framework
• Writing and / or review of documentation which support GxP activities for accuracy, completeness, compliance and user friendliness, e.g., SOPs, instructions, validation documentation
• Leading, coordinating, or performing deviation investigations
• Management / Implementation of Corrective and Preventive Measures, Change Controls and Software Life Cycle Controls.
• Providing training to other parts of the business on the Quality Management Systems
• Participating in internal and external audits and implementing any resulting recommendations / actions
• Reviewing and evaluating customer complaints; supporting root cause determination and risk assessments as necessary
• Consideration to General Data Protection Regulation (GDPR) in documentation
• To undertake any further duties, from time to time as may be reasonably required
• Successful, timely completion of goals and objectives that strengthen the Organisation.
• Progress reporting against deadlines Requirements : Essential
• Understanding of relevant quality regulations, such as ISO 9001 and GxP e.g., Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
• At least 3-5years of experience in Quality Assurance within a regulated industry, particularly in pharmaceutical / life science industries. Desired :
• Knowledge in GAMP, Good Automation Management Systems
• Experience in working with quality compliance software and / or Computer Software Validati Skills : QA quality QMS deviations