Corporate Quality Auditing Senior Specialist
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Date: 10 Apr
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Department: Corporate Quality Operations
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Business Area: Quality
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Job Type: Direct Employee
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Contract Type: Permanent
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Location: Parma, IT
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This is what you will do
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Carrying out GMP/ISO audits of GMD contractors in full authonomy
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Drafting quality agreements
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Ensuring supplier qualification and validation according to GxP requirements and Chiesi quality standards
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Ensuring the quality of global suppliers and monitoring their quality performance.
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You will be responsible for
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Within the scope of Good Manufacturing Practices (GMP), Good distribution practices (GDP) and ISO : standards:
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Collaborating in internal/external audit activities at every stage:
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Planning and updates
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Collaborates in the issuing of annual audit plans (internal/external)
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Preparation (material collection, procedures, other official documentation)
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Drafting of the Audit agenda
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Contacts to be made with the supplier to be inspected
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Conducting the audit in Europe and Worldwide
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Drafting of the report in English
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Check proposed corrective actions
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Keeps the progress of audits updated, monitoring the progress and closure of corrective action
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Verification of the effectiveness of corrective actions
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Draws up synoptic tables on the general situation of the Audits (useful activity also for management review)
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Participating in the drafting of the main sector operating procedures, defining their structure, requirements, etc.
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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
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Keeps up-to-date the procedure related to GxP audits and related instruction, template, user guide
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Participes to the review of procedure and documentation related to the supply chain map, quality agreement
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Participating in investigations into non-conformities of materials in acceptance
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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
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Participates in evaluations of change control in relation with suppliers, CMO, and GxP service providers
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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.
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Insert the change impact in the QMS
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Follow and execute the pre and post-implementation actions supporting the changes
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Participating in maintenance of quality statements from GxP suppliers
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Keeps up-to-date the quality statements from global GxP suppliers (TSE/BSE, ...)
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Provides information to regulatory compliance for the issue of product statement required for the dossier
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Conducting component supplier validation which includes:
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A preliminary supplier evaluation phase (minimum requirements)
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The evaluation of product quality requirements in collaboration with other company functions involved with DLC/Procurement
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Drafting of the validation report for suppliers of Raw Materials and Packaging Materials.
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Periodic drafting of the \\\"Table of Validated Suppliers of Raw Materials and Packaging Materials\\\"
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Qualitatively evaluating Contractors
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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
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You will need to have
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Degree in scientific disciplines (Pharmacy, CTF, Biology, Chemistry, etc.)
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5 yrs experience in auditing activities of sterile, biological medicinal products
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Good spoken and written English
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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)
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Expertise on pharmaceutical products, sterile products manufacturing and control, biotechnology products
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Expertise in auditing practices and previous activity as supplier quality assurance
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We would prefer for you to have
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Auditor qualification or QP certification.
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ISO :**** Corporate Quality Systems evaluator qualification
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GMP Auditor qualifications or certificates of participation in courses in the sector issued by specialized companies (APIC, PDA, ECA, etc.)
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Soft Skills
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Customer orientation
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