Corporate Quality Auditing Senior SpecialistDate: 10 Apr 2026Department: Corporate Quality OperationsBusiness Area: QualityJob Type: Direct EmployeeContract Type: PermanentLocation: Parma, ITThis is what you will do
Carrying out GMP/ISO audits of GMD contractors in full authonomyDrafting quality agreementsEnsuring supplier qualification and validation according to GxP requirements and Chiesi quality standardsEnsuring the quality of global suppliers and monitoring their quality performance.
You will be responsible forWithin the scope of Good Manufacturing Practices (GMP), Good distribution practices (GDP) and ISO 9001:2015 standards:
Collaborating in internal/external audit activities at every stage:
Planning and updatesCollaborates in the issuing of annual audit plans (internal/external)Preparation (material collection, procedures, other official documentation)Drafting of the Audit agendaContacts to be made with the supplier to be inspectedConducting the audit in Europe and WorldwideDrafting of the report in EnglishCheck proposed corrective actionsKeeps the progress of audits updated, monitoring the progress and closure of corrective actionVerification of the effectiveness of corrective actionsDraws up synoptic tables on the general situation of the Audits (useful activity also for management review)
Participating in the drafting of the main sector operating procedures, defining their structure, requirements, etc.
Keeps up-to-date the procedures related to GxP suppliers and service providers qualification, validation, maintenance, and quality risk management, and related instruction, template, user guideKeeps up-to-date the procedure related to GxP audits and related instruction, template, user guideParticipes to the review of procedure and documentation related to the supply chain map, quality agreement
Participating in investigations into non-conformities of materials in acceptance
Maintains 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
Participates in evaluations of change control in relation with suppliers, CMO, and GxP service providers
Evaluates 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 QMSFollow and execute the pre and post-implementation actions supporting the changes
Participating in maintenance of quality statements from GxP suppliers
Keeps up-to-date the quality statements from global GxP suppliers (TSE/BSE, ...)Provides information to regulatory compliance for the issue of product statement required for the dossier
Conducting component supplier validation which includes:
A preliminary supplier evaluation phase (minimum requirements)The evaluation of product quality requirements in collaboration with other company functions involved with DLC/ProcurementDrafting of the validation report for suppliers of Raw Materials and Packaging Materials.Periodic drafting of the \"Table of Validated Suppliers of Raw Materials and Packaging Materials\"
Qualitatively evaluating Contractors:
Collaborates 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
You will need to have
Degree in scientific disciplines (Pharmacy, CTF, Biology, Chemistry, etc.)5 yrs experience in auditing activities of sterile, biological medicinal productsGood spoken and written EnglishKnowledge 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)Expertise on pharmaceutical products, sterile products manufacturing and control, biotechnology productsExpertise in auditing practices and previous activity as supplier quality assurance
We would prefer for you to have
Auditor qualification or QP certification.ISO 9001:2015 Corporate Quality Systems evaluator qualificationGMP Auditor qualifications or certificates of participation in courses in the sector issued by specialized companies (APIC, PDA, ECA, etc.)
Soft Skills
Customer orientationGoal orientationQuality orientation
BenefitsNo matter where your path starts at Chiesi, it leads to inspiring possibilities. 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.We 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.Chiesi is an equal opportunity employer committed to hiring a diverse workforce at all levels of our business. 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.#J-18808-Ljbffr