Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **General Purpose of Role:** • Maintain, support and improve the Pharmaceutical Quality System employed within PCI. • Lead site activities in relation to computer systems validation. **Main Responsibilities:** • Manage and deliver specific validation projects according to business priorities. • Write, review and approve validation documentation. • Co-ordinate completion of annual computerised system reviews. • Technical system Owner/Administrator for the site e-Document Management System and e-Quality Management System. • Owner of site risk register and maintenance of Quality Risk Management and Data Integrity assessments. • Line management responsibility for Quality Officers and/or Quality Administrators within the QMS stream. • Represent the Bridgend Quality department for key client accounts. • Reporting of metrics for systems within scope of responsibility. • Support and host client audits of the PCI Bridgend facility. • Support regulatory inspections of the PCI Bridgend facility. • Support delivery of site/departmental projects and objectives. • Support continuous improvement, validation and technical services activities. • Author standard operating procedures. • Provide QA and GMP related training. • Additional duties as required with job level **Outcomes of Role:** • Maintain validated status of site GxP computerised systems. • Co-ordinate site CSV projects. • Maintenance of the compliance of site QMS. \#LI-JP1 Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/) **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled