Corporate Quality Auditing Senior Specialist

Corporate Quality Auditing Senior Specialist

We are looking for an experienced GMP Auditor with a strong track record in supplier and external partner audits within the pharmaceutical industry. This role is primarily focused on planning and performing international audits of GxP suppliers and contractors, ensuring full compliance with GMP, GDP and ISO standards:

Carrying out GMP/ISO audits of GMD contractors in full autonomy

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:

• Collaborating in internal/external audit activities at every stage:
• Perform on-site audits across Europe and worldwide
• Prepare audit agendas, lead audit execution, and write reports in English
• Collaborates in the issuing of annual audit plans (internal/external)
• Preparation (material collection, procedures, other official documentation)
• Contacts to be made with the supplier to be inspected
• 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.
• Keeping 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
• Keeping up-to-date the procedure related to GxP audits and related instruction, template, user guide
• Participates 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
• Participates 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:

• Minimum 5 years of hands-on experience as GMP Auditor (as lead auditor or active co-auditor – not only audit hosting or support)
• Proven experience in supplier / contractor audits
• Strong knowledge of: GMP (EU & FDA – Eudralex, 21 CFR 210/211) GDP and/or ISO standards
• Degree in scientific disciplines (Pharmacy, CTF, Biology, Chemistry, etc.)
• 5 yrs experience in auditing activities of sterile, biological medicinal products
• Expertise in sterile, biological or biotechnological products
• Good spoken and written English
• We would prefer for you to have Formal GMP Auditor qualification or certification (e.g. APIC, PDA, ECA or equivalent)
• ISO 9001 auditor qualification
• Experience auditing external manufacturing / CMOs / global suppliers

Soft Skills:

• Customer orientation
• Communication skills
• Proactiveness
• Goal orientation
• Quality orientation

Location: The role offers flexibility, allowing candidates to be based across Europe, with regular travel to Parma required.

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.