Corporate Quality Auditing Senior Specialist
Parma, IT
About us
Chiesi is an international research-focused biopharmaceutical group with 90 years’ experience, operating in more than 30 countries, with its Headquarter in Parma, Italy. More than 8,000 employees across the group are united by a singular purpose: promoting a healthier world for our people, patients, and the planet. This is what drives us as we research, develop, and market innovative drugs across our main therapeutic areas. Discover more here.
At Chiesi we are thinking generations ahead, driving sustainable innovation with purpose. This fosters a culture of reliability, transparency, and ethical behaviour at every level. As a Benefit Corporation and a certified B Corp, we have embedded sustainability in our bylaws and continuously measure our impact.
Diversity and inclusion are at the heart of who we are. We believe our differences make us stronger. We are a vibrant ecosystem of passionate, talented individuals united by strong values, each bringing unique perspectives that help us to continuously challenge the status quo for the better.
Global Technical Operations & Supply
Global Technical Operations & Supply (Global TechOp&S) is Chiesi’s global manufacturing and supply area, responsible for ensuring consistent, outstanding quality, service and value across our end‑to‑end supply chain. Global TechOp&S oversees the entire lifecycle of the drug: from process optimization and industrialization, to manufacturing, engineering, quality oversight, and supply chain management. Throughout this journey, Operational Excellence drives continuous improvement. This end‑to‑end model is powered by our four manufacturing sites - Parma (IT), Blois (FR), Santana de Parnaíba (BR), and Nerviano (IT) - together with our Virtual Plant network of external partners.
Who we are looking for
This is what you will do
- Carrying out GMP/ISO audits of GMD contractors in full authonomy
- Drafting quality agreements
- Ensuring supplier qualification and validation according to GxP requirements and Chiesi quality standards
- Ensuring the quality of global suppliers and monitoring their quality performance.
You will be responsible for
Within 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 updates
- Collaborates in the issuing of annual audit plans (internal/external)
- Preparation (material collection, procedures, other official documentation)
- Drafting of the Audit agenda
- Contacts to be made with the supplier to be inspected
- Conducting the audit in Europe and Worldwide
- Drafting of the report in English
- Check proposed corrective actions
- Keeps the progress of audits updated, monitoring the progress and closure of corrective action
- Verification of the effectiveness of corrective actions
- Draws 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 guide
- Keeps up-to-date the procedure related to GxP audits and related instruction, template, user guide
- Participes 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 QMS
- Follow 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/Procurement
- Drafting 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 products
- Good spoken and written English
- Knowledge 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 products
- Expertise 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 qualification
- GMP Auditor qualifications or certificates of participation in courses in the sector issued by specialized companies (APIC, PDA, ECA, etc.)
Soft Skills
Location
Parma
What we offer
No 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.
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