Join to apply for the Corporate Quality Auditor role at Chiesi GroupBased in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees. The Group researches, develops and markets innovative drugs in its main therapeutic areas. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels. We are committed to embrace diversity, inclusion and equal opportunities.Chiesi Global Manufacturing DivisionChiesi Group has three production plants: Parma (Italy); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The Parma plant is a strategic hub for production and distribution, exporting to more than 80 countries. The Parma plant produces solid medicinal products, inhalation solutions and suspensions, and several liquid forms.Who we are looking forPurposeThe collaborator will be specialized in:Carrying out GMP/ISO audits of GMD contractors in full autonomyDrafting quality agreementsEnsuring supplier qualification and validation according to GxP requirements and Chiesi quality standardsEnsuring the quality of global suppliers and monitoring their quality performanceMain ResponsibilitiesWithin the scope of GMP, GDP and ISO 9001:2015 standards:Collaborates in internal/external audit activities at every stage:Planning and updatesCollaborates in issuing annual audit plans (internal/external)Preparation (material collection, procedures, other official documentation)Drafting the Audit agendaContacts with the supplier to be inspectedConducting the audit in Europe and WorldwideDrafting the report in EnglishCheck proposed corrective actionsMonitor progress and closure of corrective actionsVerify effectiveness of corrective actionsDraw up synoptic tables on the general audit situation for management reviewParticipates in drafting main sector operating procedures, defining structure and requirementsKeeps procedures related to GxP suppliers and service providers qualification, validation, maintenance, and quality risk management up to dateKeeps procedures related to GxP audits up to dateReviews supply chain map, quality agreementsParticipates in investigations into non-conformities of materials in acceptanceMaintains contact with internal representatives and global suppliers to promote removal of non-conformities and implement corrective actionsParticipates in evaluations of change control in relation with suppliers, CMO, and GxP service providersEvaluates impacts on qualification of GxP suppliers, CMO, services providersIncorporates change impact into the QMSFollows pre- and post-implementation actions supporting changesParticipates in maintenance of quality statements from GxP suppliersKeeps up-to-date the quality statements from global GxP suppliersProvides information to regulatory compliance for product statements required for dossiersConducts component supplier validation, including:Preliminary supplier evaluation (minimum requirements)Evaluation of product quality requirements with other functionsDrafting of the validation report for Raw Materials and Packaging Materials suppliersPeriodic drafting of the "Table of Validated Suppliers of Raw Materials and Packaging Materials"Qualitatively evaluate ContractorsCollaborates with QA/AUH to calculate supplier quality factors and overall reliability scoresExperience Required5-10 years of auditing experience in sterile, biological medicinal productsExperience as supplier quality assuranceEducationLanguagesGood spoken and written English. Italian, French or Spanish are valuable integrative skills.Technical SkillsKnowledge of national and international pharmaceutical legislation including DL 219, Eudralex Vol. IV, 21CFR parts 210, 211ISO 9001:2015Expertise in pharmaceutical products, sterile products manufacturing and control, biotechnology productsPreferred SkillsAuditor qualification or QP certificationISO 9001:2015 Corporate Quality Systems evaluator qualificationGMP Auditor qualifications or training (APIC, PDA, ECA, etc.)Soft SkillsCustomer orientationGoal orientationWhat we offerYou would join a dynamic, fast-growing, challenging and friendly environment.We believe that our people are our most valuable asset, and we invest in continuous training and development. We strive to promote a high-quality working environment and collective well-being.We want our people to come to work happy every day, and we support work-life balance with flexible working, remote options, relocation assistance, tax support for foreign colleagues and other people-care services.Seniority level: AssociateEmployment type: Full-timeJob function: Quality AssuranceIndustries: Pharmaceutical ManufacturingIsExpired: false
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