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 : To perform a Quality Operational role which supports: - Management andexecution of all QualityInvestigationsandproceduralupdatesthatare the responsibility of the operationaldepartments. - Maintain, support andimprove the PharmaceuticalQuality System employedwithinPCI, specifically to improveproceduresandimplementCAPA'sinrelations to Operations proceduresandprocesses, withzerooverduewithoutanextension. - CollateandmanageoperationsKPI'sandmetrics. - A leaduserforsite QMS system within Operations. Main Responsibilities : - Support Operations withinvestigatinganddraftingQualityEventInvestigationswithinstandardtimelinesandcapturetemperatureexcursionsforshipments. - Ensuretimelycompletion of deviationinvestigationsinconjunctionwith Operations, PM, QC and QA departments. - Support Operations incompleting CAPA actionswithinstandardtimelinesworkingwith the appropriatedepartments to facilitatedeviationclosure. - Administration, controland support coresystemswithin the PharmaceuticalQuality System as allocated by departmentmanager. Includingbut not limited to: QIR/complaints, CAPA, Changecontrolanddocumentcontrolsystems. - WorkcloselywoithOperationalpersonnel to developdepartmentaltechnicalwritingskillsandimporveprocessessandprocedures. - Reportingof metricsforsystemswithinscope of responsibility, e.g Client QBR support. - Provideinformationandgivefeedbackonprogress of deviations/investigationsthatmayimpactbatchrelease. - Attenddeviationmeetingsandgiveappropriatefeedbackfordeviationstatusandprogression - Support delivery of siteOperationalprojectsandobjectives. - Support thesite'sContinuousImprovementactivitiesandmaturityindexthrough the one PCI initiative. - Writeoperationalrelatedstandardoperatingprocedures, SOI'sand WI. Outcomes of Role : - Co-ordinateandperformInvestigationsintointernalandexternalqualityissues. - Submissionandapprovals of completedinvestigations, CAPA'sandchangecontrols. - Completeproceduralupdates to controlledOperationaldocumentationincludingbut not restricted to SOP's, SOI'sandForms. - Operationalreportingandmetricsontimeandgreater than target Specific Qualifications : A HND or equivalent in a business, quality or life sciences subject and / or suitable experience within an operational, quality assurance or technical role within the pharmaceutical industry. Previous Work Experience : Essential Meets one of the following requirements: - Experiencein a Quality/Technicalrolewithin a regulatedindustry(pharmaceutical, biotechnology, medicaldevice). - Experiencein a QualityAssurance/TechnicalWriterrolewithin aregulatedindustrywithtransferableskills (e.g. Aerospace, food, automotive) - Experience of technicalwriting, RootCauseInvestigationandimplementation of CAPA. Desirable - Knowledge of cGXP, regulatoryrequirementsandappropriate ISO standards. - Experience of InvestigationalMedicinal Products, Biotechnologyand EU/US clinicaltrials is highlydesirable. Specific Knowledge /_ _Skills Competence : - Strongwrittenandverbalcommunicationskills. - The ability to introduce, co-ordinate, completeandreportonprojects. - A highlevel of self-motivation is required - Able to rationallypersuadeandpositivelyInfluence - Ability to manageconflictandmakesoundscientificallybaseddecisions. - IT literate (experience of e-QMS/document management systemsand ERP systemsdesirable). Behavioral Competencies : Communication skills - Must be able to communicate at all levels (internally and externally), using different methods and techniques ranging from written reports to formal presentations. Interpersonal skills - Able to form and maintain relationships at all levels is essential Thinking and decision making - The successful candidate often need to make decisions and advise on appropriate courses of action in the event of a Quality incident or to agree appropriate Corrective and Preventative actions. The role includes the requirement to occasionally travel on company business. - 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, 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