GCP Compliance Specialist

3 settimane fa

Parma, Italia Chiesi A tempo pieno
About usBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years’ experience, operating in 30 countries with more than 6,000 employees (Chiesi Group). To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas: Discover more hereWe are proud to be the largest global pharmaceutical group to be awarded B Corp Certification, a recognition of high social and environmental standards. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels.We believe that the success of Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors. Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. Chiesi Research & DevelopmentOur R&D team represents a fundamental asset for the business. It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, R&D project and portfolio management.

Headquartered in the new purpose-built and fully integrated Research and Development Centre in Parma (Italy), the team also has important operations in Paris (France), Chippenham (UK), Cary (US), Stockholm (Sweden) and Toronto (Canada).Who we are looking forPurposeTo verify and ensure the compliance and the correct application of Good Clinical Practices (GCP) being primarily responsible for the management of all the GCP CAPAs, preparation of the quality metrics, KPIs supporting the compliance inside Global R&D Departments, management of Quality Documents and by execution of first and second party audits.Main ResponsibilitiesManagement of CAPA Plans from GCP auditsManagement of the requests for the collection of quality metrics, KPIs supporting Global R&D DepartmentsManagement of Trackwise, Suppliers and Audit workflowsSupport the management of external consultants supporting the Auditing & Supplier Qualification Unit.Finalization of Quality Documents supporting the Auditing & Supplier Qualification Unit.Write/Review SOPs relating to audit and qualification of clinical service providersEnsure training on relevant activities and proceduresEnsure good documentation and traceabilityExecution of GCP first and second party audits Finalization and management of the GCP audit reportsExperience RequiredAt least 3 years’ experience in Pharmaceutical, Consultancy Companies or Contract Research Organization in the Research & Development

environment

Quality Assurance with robust knowledge of GCP supporting clinical trials and knowledge of compliance. ISO auditor Certification to be considered an added valueEducationScientific degreeLanguagesGood knowledge of EnglishTechnical SkillsKnowledge of GCP requirements and quality systemKnowledge of the pharmaceutical development process supporting clinical trialsKnowledge of training techniqueKnowledge of auditing technique to be considered an added valueSoft SkillsPlanning and organizational skills Strategic thinking Team working Quality orientation Communication skills What we offerYou would join a dynamic, fast-growing, challenging and friendly environment. In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.We want our people to come to work happy every day, and we know how important it is to find the right work-life balance in order to be able to give our best. That is why we offer flexible working approach, remote working, support in the relocation process, tax assistance service for foreign colleagues and many other people-care services.

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