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 controlled documentation within the company's electronic document management system and provide general administrative support to the QA Department. Main Responsibilities : - Manage documents within the e-QMS - Create new GxP documents within e-QMS - Track and facilitate document change requests - Communicate document review requirements to department managers - Produce monthly document status reports - Control the issue, distribution and withdrawal of e-documents - Issue documents for training - Write and author Standard Operating Procedures and instructional documents within scope of duties - Coordinate scanning and archiving of hardcopy documents - Manage QA/QP and Client audit calendars - Support client audit arrangements (as required) - Administration of batch records for QP review - General administration tasks (e.g. Travel arrangements, completion of purchase orders, meeting minutes etc.) - Assist with GMP software validation as required - Other duties as required with job level Outcomes of Role : - Support the Head of QMS in maintaining controlled documents in line with GxP requirements - Support site personnel by facilitating document creation and change - Become a subject matter expert for electronic document management system - Ensure all hardcopy documents are appropriately controlled and archived 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