Corporate Quality Auditing Specialist

Who we are looking for

Purpose

The collaborator will be specialized in:

- Carrying out GxP/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.

Main Responsibilities

Within the scope of Good Manufacturing Practices (GMP), Good distribution practices (GDP) and ISO 9001:2015 standards:



- Collaborates 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)





- Participates 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





- Participates 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 SO Ps 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





- Conducts 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 evaluate 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





Experience Required




• At least 5 years in quality management areas, preferably with 2+ years in auditing roles.





Preferred:






• Experience in the manufacturing process of sterile medicinal products or inhalation products, and/or in the validation activities for the production of medicinal products.



• Previous activity as GMP or ISO Auditor in pharmaceutical companies.



• Previous activity as supplier quality assurance.





Education

Graduates in scientific disciplines ( Pharmacy, CTF, Biology, Chemistry, etc. )

Languages
Good spoken and written English.

Italian, French or Spanish will constitute an important integrative skill.

Technical Skills




• 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)



• ISO 9001:2015 regulation



• Expertise on pharmaceutical products, sterile products manufacturing and control, biotechnology products.



• Expertise in auditing practices





Preferred Skills




• 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


• Customer orientation



• Communication skills



• Proactiveness



• Goal orientation



What we offer


You would join a dynamic, fast-growing, challenging and friendly environment.

In Chiesi we firmly believe that our people are our most valuable asset, that is why we invest in continuous training, learning and development. Therefore, we strive to continuously promote and satisfy development needs, paying particular attention to the quality of our working environment and to collective well-being.

We want our people to come to work happy every day, and we know how important it is to find the right work-life balance 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.