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 proud to have been awarded with B Corp Certification, recognizing high social and environmental standards. We are a reliable company that adopts and promotes transparent and ethical behavior at all levels.
We believe that the success of Chiesi is built by our people and our shared Values and Behaviors. We attract and retain talent who live and breathe our values and behaviors.
We are committed to embrace diversity, inclusion and equal opportunities. We are a global family made up of different cultures, genders, generations, ethnicities, abilities, sexual identities and many other diversities.
Chiesi Global Manufacturing Division
Chiesi Group has three production plants: Parma (Italy); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The plants produce a total of over 110 million units per year.
The Parma plant covers a total area of more than fifteen thousand square meters and is the strategic hub for production and distribution, exporting to more than 80 countries. The Parma plant produces solid medicinal products, inhalation solutions and suspensions, and other dosage forms.
Santana produces inhalation solutions and suspensions. Blois specializes in Dry Powder Inhalers and final assembly stages of MDIs.
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; annual audit plans; preparation; audit agenda; supplier contacts; audits in Europe and worldwide; reporting in English; proposed corrective actions; audit progress tracking and closure; verification of effectiveness; synoptic audits for management review.
Participates in drafting sector operating procedures and keeps GxP supplier/service provider qualification, validation, maintenance, and quality risk management procedures up to date.
Participates in investigations into non-conformities of materials in acceptance and coordinates with internal and global supplier representatives to implement corrective actions.
Evaluates change control impacts related to suppliers, CMO, and GxP service providers; follows pre/post-implementation actions and updates QMS.
Maintains quality statements from global GxP suppliers and provides information for regulatory dossiers.
Conducts component supplier validation including preliminary evaluation, quality requirement assessment, and drafting validation reports for Raw Materials and Packaging Materials; maintains a table of validated suppliers.
Qualitatively evaluates Contractors and collaborates to calculate supplier quality factors and reliability judgments.

Experience Required

5-10 years of experience in auditing activities of sterile, biological medicinal products
Previous activity as supplier quality assurance

Education
Languages
Good spoken and written English. Italian, French or Spanish is an integrative skill.
Technical Skills

Knowledge of national and international pharmaceutical legislation (e.g., 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 related courses (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 invest in continuous training and development, promote a positive working environment and well-being, and support work-life balance with flexible and remote working options, relocation assistance, and other people-care services.
Seniority level

Associate

Employment type

Full-time

Job function

Quality Assurance

Industries

Pharmaceutical Manufacturing

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