Corporate Quality Auditor

Join to apply for the Corporate Quality Auditor role at Chiesi Group

Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with 90 years’ experience, operating in 31 countries with more than 7,000 employees. The Group researches, develops and markets innovative drugs in its main therapeutic areas. We are a reliable company that adopts and promotes a transparent and ethical behavior at all levels. We are committed to embrace diversity, inclusion and equal opportunities.

Chiesi Global Manufacturing Division

Chiesi Group has three production plants: Parma (Italy); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The Parma plant is a strategic hub for production and distribution, exporting to more than 80 countries. The Parma plant produces solid medicinal products, inhalation solutions and suspensions, and several liquid forms.

Who we are looking for

Purpose

The collaborator will be specialized in:

• 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

Main Responsibilities

Within the scope of GMP, GDP and ISO 9001:2015 standards:

• Collaborates in internal/external audit activities at every stage:
• Planning and updates
• Collaborates in issuing annual audit plans (internal/external)
• Preparation (material collection, procedures, other official documentation)
• Drafting the Audit agenda
• Contacts with the supplier to be inspected
• Conducting the audit in Europe and Worldwide
• Drafting the report in English
• Check proposed corrective actions
• Monitor progress and closure of corrective actions
• Verify effectiveness of corrective actions
• Draw up synoptic tables on the general audit situation for management review

• Participates in drafting main sector operating procedures, defining structure and requirements
• Keeps procedures related to GxP suppliers and service providers qualification, validation, maintenance, and quality risk management up to date
• Keeps procedures related to GxP audits up to date
• Reviews supply chain map, quality agreements

• Participates in investigations into non-conformities of materials in acceptance
• Maintains contact with internal representatives and global suppliers to promote removal of non-conformities and implement corrective actions

Participates in evaluations of change control in relation with suppliers, CMO, and GxP service providers

• Evaluates impacts on qualification of GxP suppliers, CMO, services providers
• Incorporates change impact into the QMS
• Follows pre- and post-implementation actions supporting changes

Participates in maintenance of quality statements from GxP suppliers

• Keeps up-to-date the quality statements from global GxP suppliers
• Provides information to regulatory compliance for product statements required for dossiers

Conducts component supplier validation, including:

• Preliminary supplier evaluation (minimum requirements)
• Evaluation of product quality requirements with other functions
• Drafting of the validation report for Raw Materials and Packaging Materials suppliers
• Periodic drafting of the "Table of Validated Suppliers of Raw Materials and Packaging Materials"

Qualitatively evaluate Contractors

• Collaborates with QA/AUH to calculate supplier quality factors and overall reliability scores

Experience Required

• 5-10 years of auditing experience in sterile, biological medicinal products
• Experience as supplier quality assurance

Education

Languages

Good spoken and written English. Italian, French or Spanish are valuable integrative skills.

Technical Skills

• Knowledge of national and international pharmaceutical legislation including DL 219, Eudralex Vol. IV, 21CFR parts 210, 211
• ISO 9001:2015
• Expertise in pharmaceutical products, sterile products manufacturing and control, biotechnology products

Preferred Skills

• Auditor qualification or QP certification
• ISO 9001:2015 Corporate Quality Systems evaluator qualification
• GMP Auditor qualifications or training (APIC, PDA, ECA, etc.)

Soft Skills

• Customer orientation
• Goal orientation

What we offer

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

We believe that our people are our most valuable asset, and we invest in continuous training and development. We strive to promote a high-quality working environment and collective well-being.

We want our people to come to work happy every day, and we support work-life balance with flexible working, remote options, relocation assistance, tax support for foreign colleagues and other people-care services.

Seniority level: Associate

Employment type: Full-time

Job function: Quality Assurance

Industries: Pharmaceutical Manufacturing

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