Senior QA GCP Specialist and Auditor

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Global RD Quality Assurance /p pBusiness Area: Quality /p pJob Type: Direct Employee /p pContract Type: Permanent /p pLocation: Parma, IT /p pAbout us /p pChiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. p pAt Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. As a Agevolazioni Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact. /We believe our differences make us stronger. p pChiesi Research Development /p pOur RD team represents a fundamental asset for the business.

It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery technology, clinical development, regulatory affairs, pharmacovigilance, intellectual property, quality assurance, RD 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), Toronto (Canada) and Shanghai (China). /p pWho we are looking for /p h3This is what you will do /h3 pThe role will be responsible to 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 RD Departments, management of Quality Documents and by execution of first and second party audits at clinical studies and vendors.



/p h3You will be responsible for /h3 ul liManagement of CAPA Plans from GCP audits /li liManagement of the requests for the collection of quality metrics, KPIs supporting Global RD Departments /li liManagement of Trackwise/Quality Management system, Suppliers and Audit workflows /li liSupport the management of external consultants supporting the Auditing, Due Diligence Supplier Qualification Unit. /li liFinalization of Quality Documents supporting the Auditing, Due Diligence Supplier Qualification Unit. /li liWrite/Review SOPs relating to audit and qualification of clinical service providers /li liEnsure training on GCP relevant activities and procedures /li liEnsure good documentation and traceability /li liExecution of GCP first and second party audits at clinical studies and vendors /li liFinalization and management of the GCP audit reports /li liInteract with Clinical Departments, Pharmacovigilance and Procurement /li /ul h3You will need to have /h3 ul liAt 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 /li liAt least 2 years of experience as GCP auditor /li liKnowledge of GCP requirements and quality system /li liKnowledge of the pharmaceutical development process supporting the whole panel of clinical trials (Phase I, II, III and IV)



/li liKnowledge of training technique /li liKnowledge of auditing techniqueFluent English, written and spoken /li /ul pPlanning and organizational skills /p pStrategic thinking /p ul liQuality orientation /li /ul h3We would prefer for you to have /h3 ul liISO auditor Certification to be considered an added value /li /ul h3Location /h3 pThepositionisbasedatourheadquartersinParmaandoffersaflexiblehybridworkingarrangement. /The final offer will reflect the candidate’s skills, experience, qualifications and internal equity considerations. /p pThis role is eligible to participate in an annual bonus scheme, subject to company and individual performance. /p pIn addition, we offer a comprehensive benefits package including pension, private medical insurance, wellbeing programme, flexible benefits programme and more. /Your future is our focus, and we are committed to nurturing your development in our dynamic, friendly environment with access to resources and training every step of the way. /p pWe provide top-class benefits, including comprehensive healthcare programs, work-life balance initiatives, and robust relocation support. Our salary package is competitive, comprising a basic salary, performance bonuses, and benefits benchmarked against the external market.

Additionally, we offer flexible working arrangements, remote work options, and tax assistance services for foreign colleagues, all designed to help you thrive. /All qualified applicants receive consideration for employment based on attitude and merit, without regard to race, national origin, age, sex, religion, disability, sexual orientation, marital status, military status, gender identity or expression, or any other basis protected by applicable laws. This policy applies to all aspects of employment, including hiring, transfer, promotion, compensation, eligibility for benefits, and termination. /

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8mzthe