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-QMSMaintain client supplied documentsUpdate Supplier module with new entitiesUpload documents into audit moduleTrack audits to closureMaintain schedule of required auditsManage documents through their electronic signature lifecycle.Assist staff with travel arrangementsManage and schedule new work into the QRS programmeManage monthly billing ensuring all completed work is billed forEnsure all expenses are complete and submitted for billingOther duties as required with job levelDesirable Qualifications
NVQ/HND/HNC/Degree level educated (or equivalent)Specific Knowledge / Skills Competence
Advanced working knowledge of MS WordGood working knowledge of MS office packages (Excel, Visio, PowerPoint)Knowledge and experience working with SmartsheetsBasic understanding of document control requirementsAbility to write logical and coherent documentationLiteracy skillsNumeracy skills and ability to report financial informationExcellent written and communication skillsAdministration of controlled documentsAdministration of document archiving systemsDesirable
Knowledge of Quality Management SystemsUnderstanding of EU GxPBehavioural Competencies:
Ability to work autonomously with minimal supervisionAbility to prioritise individual workload in line with department goals and objectivesExcellent written and verbal communication.Good attention to detailJoin us and be part of building the bridge between life changing therapies and patients. Let’s talk future
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.