PSelect how often (in days) to receive an alert: /ph3Corporate Quality Auditing Specialist - Temporary /h3pDate: 20 Aug 2025 /ppDepartment: Corporate Quality Operations /ppBusiness Area: Industrial Operations HSE /ppJob Type: Direct Employee /ppContract Type: Temporary /ppLocation:pParma, IT /p /ppbemAbout us /em /b /ppBased 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: bDiscover more here /b /ppWe are proud to be the largest global pharmaceutical group to be awarded bB Corp Certification /b, a recognition of bhigh social and environmental standards /b. We are a breliable /b company that adopts and promotes a btransparent and ethical behavior /b at all levels. /ppWe believe that the success of bChiesi is built and shaped by our people and our strong set of shared Values and Behaviors /b. 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. /ppWe are committed to bembrace diversity, inclusion and equal opportunities. /b In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities. /ppbemChiesi Global Manufacturing Division /em /b /ppChiesi Group has three production plants: /ppbParma /b (Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries. Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced. /ppIn 2024, a new bBiotech Centre of Excellence /b has launched in Parma. The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins. /ppbBlois-La Chaussée Saint Victor plant /b (France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs). The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs. /ppbSantana de Parnaiba /b (Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs). Additionally, it has an area dedicated to nasal sprays for the European market. Santana produces pressurised solutions and suspensions for inhalation therapy (MDI). /ppIn 2025, a new investment in bNerviano /b (Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company’s commitment to both patients’ health and sustainable healthcare solutions), dry powder inhalers and sterile biological products. /ppbemWho we are looking for /em /b /ph3ubPurpose /b /u /h3pWe are looking for a Corporate Quality Auditing Specialist to join our corporate team on a temporary contract. /ppThe collaborator will be specialized in:br- Carrying out GxP/ISO audits of GMD contractors in full authonomy,br- Drafting quality agreements,br- Ensuring supplier qualification and validation according to GxP requirements and Chiesi quality standards,br- Ensuring the quality of global suppliers and monitoring their quality performance. /ph3ubMain Responsibilities /b /u /h3pWithin the scope of Good Manufacturing Practices (GMP), Good distribution practices (GDP) and ISO 9001:2015 standards: /pulliCollaborates in internal/external audit activities at every stage:ulliPlanning and updates /liliCollaborates in the issuing of annual audit plans (internal/external) /liliPreparation (material collection, procedures, other official documentation) /liliDrafting of the Audit agenda /liliContacts to be made with the supplier to be inspected /liliConducting the audit in Europe and Worldwide /liliDrafting of the report in English /liliCheck proposed corrective actions /liliKeeps the progress of audits updated, monitoring the progress and closure of corrective action /liliVerification of the effectiveness of corrective actions /liliDraws up synoptic tables on the general situation of the Audits (useful activity also for management review) /li /ul /liliParticipates in the drafting of the main sector operating procedures, defining their structure, requirements, etc.ulliKeeps up-to-date the procedures related to GxP suppliers and service providers qualification, validation, maintenance, and quality risk management, and related instruction, template, user guide /liliKeeps up-to-date the procedure related to GxP audits and related instruction, template, user guide /liliParticipates to the review of procedure and documentation related to the supply chain map, quality agreement /li /ul /liliParticipates in investigations into non-conformities of materials in acceptanceulliMaintains contact with the internal representative and the global supplier in order to promote the removal of non-conformities, which caused the problems with the material supplied, and the implementation of the necessary corrective actions /li /ul /liliParticipates in evaluations of change control in relation with suppliers, CMO, and GxP service providersulliEvaluates the impacts on the qualification of GxP suppliers, CMO, services providers, and related GxP audits, quality agreement, validation report, and supporting data, information and SOPs of the unit. Insert the change impact in the QMS /liliFollow and execute the pre and post-implementation actions supporting the changes /li /ul /liliParticipates in maintenance of quality statements from GxP suppliersulliKeeps up-to-date the quality statements from global GxP suppliers (TSE/BSE, …) /liliProvides information to regulatory compliance for the issue of product statement required for the dossier /li /ul /liliConducts component supplier validation which includes:ulliA preliminary supplier evaluation phase (minimum requirements) /liliThe evaluation of product quality requirements in collaboration with other company functions involved with DLC/Procurement /liliDrafting of the validation report for suppliers of Raw Materials and Packaging Materials. /liliPeriodic drafting of the "Table of Validated Suppliers of Raw Materials and Packaging Materials" /li /ul /liliQualitatively evaluate Contractors:ulliCollaborates with QA/AUH to calculate the quality factors of the Suppliers: in collaboration with the DLC/Procurement, calculates the quality score which allows you to express a judgment on the reliability of each Supplier of material or service and of the external contractors /li /ul /li /ulh3ubExperience Required /b /u /h3ulliAt least 5 years in quality management areas, preferably with 2+ years in auditing roles.brPreferred: /liliExperience in the manufacturing process of sterile medicinal products or inhalation products, and/or in the validation activities for the production of medicinal products. /liliPrevious activity as GMP or ISO Auditor in pharmaceutical companies. /liliPrevious activity as supplier quality assurance /li /ulh3ubEducation /b /u /h3h3ubLanguages /b /u /h3pGood spoken and written English.brItalian, French or Spanish will constitute an important integrative skill. /ph3ubSoft Skills /b /u /h3ulliCustomer orientation /liliGoal orientation /li /ulh3ubTechnical Skills /b /u /h3ulliKnowledge of national and international pharmaceutical legislation (in particular national laws (e.g. DL 219), European and American directives (e.g.: Eudralex VoL.IV, 21CFR part 210,211) /liliISO 9001:2015 regulation /liliExpertise on pharmaceutical products, sterile products manufacturing and control, biotechnology products. /li /ulpPreferred Skills /pulliAuditor qualification or QP certification. /liliISO 9001:2015 Corporate Quality Systems evaluator qualification /liliGMP Auditor qualifications or certificates of participation in courses in the sector issued by specialized companies (APIC, PDA, ECA, etc.) /li /ulpbemWhat we offer /em /b /ppYou would join a dynamic, fast-growing, challenging and friendly environment.brIn Chiesi we firmly believe that bour people are our most valuable asset /b, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular battention to the quality of our working environment and to collective well-being. /bbrbWe want our people to come to work happy every day /b, and we know how important it is to find the right bwork-life balance /b 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. /ph3DISCOVER ALL OUR JOB OPPORTUNITIES /h3h3Screen readers cannot read the following searchable map. /h3 #J-18808-Ljbffr