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 : Perform administrative tasks to support the QRS function. Main Responsibilities : - Manage audit documents within the e-QMS (electronic quality management system) - Create new GxP documents within e-QMS - Maintain client supplied documents - Update Supplier module with new entities - Upload documents into audit module - Track audits to closure - Maintain schedule of required audits - Manage documents through their electronic signature lifecycle. - Assist staff with travel arrangements - Manage and schedule new work into the QRS programme - Manage monthly billing ensuring all completed work is billed for - Ensure all expenses are complete and submitted for billing - Other duties as required with job level Desirable Qualifications - NVQ/HND/HNC/Degree level educated (or equivalent) Specific Knowledge / Skills Competence - Advanced working knowledge of MS Word - Good working knowledge of MS office packages (Excel, Visio, PowerPoint) - Knowledge and experience working with Smartsheets - Basic understanding of document control requirements - Ability to write logical and coherent documentation - Literacy skills - Numeracy skills and ability to report financial information - Excellent written and communication skills - Administration of controlled documents - Administration of document archiving systems Desirable - Knowledge of Quality Management Systems - Understanding of EU GxP Behavioural Competencies : - Ability to work autonomously with minimal supervision - Ability to prioritise individual workload in line with department goals and objectives - Excellent written and verbal communication. - Good attention to detail 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, Equity and Inclusion 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