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Corporate Quality Auditing Specialist - Temporary
Date: 20 Aug ****
Department: Corporate Quality Operations
Business Area: Industrial Operations & HSE
Job Type: Direct Employee
Contract Type: Temporary
Location:
Parma, IT
About us
Based in Parma, Italy, Chiesi is an international research-focused pharmaceutical and healthcare group with over 85 years' experience, operating in 30 countries with more than 6,000 employees (Chiesi Group).
To achieve its mission of improving people's quality of life by acting responsibly towards society and the environment, the Group researches, develops and markets innovative drugs in its main therapeutic areas:
Discover more here
We are proud to be the largest global pharmaceutical group to be awarded
B Corp Certification
, a recognition of
high social and environmental standards
.
We are a
reliable
company that adopts and promotes a
transparent and ethical behavior
at all levels.
We believe that the success of
Chiesi is built and shaped by our people and our strong set of shared Values and Behaviors
.
Our people make a critical difference to our success, which is why it is vital that we attract and retain the right talent who will continue to enrich our culture by living and breathing our values and behaviors.
We are committed to
embrace diversity, inclusion and equal opportunities.
In fact, we are a global family made up of different cultures, different genders, generations, ethnicities, abilities, sexual identities and many other enriching diversities.
Chiesi Global Manufacturing Division
Chiesi Group has three production plants:
Parma
(Italy), the strategic hub for the production and distribution of our products, serving as an international supply center with exports to over 80 countries.
Here, solid medicines such as tablets and dry powders for inhalers, solutions and suspensions for inhalations and sterile suspension vials for endotracheal administration are produced.
In ****, a new
Biotech Centre of Excellence
has launched in Parma.
The new facility is dedicated to developing and producing monoclonal antibodies, enzymes, and other proteins.
Blois-La Chaussée Saint Victor plant
(France), a center of excellence specializing in the production of Dry Powder Inhalers and Metered Dose Inhalers (MDIs).
The site manages direct distribution to customers in the French market and exports to other markets, effectively meeting both local and international needs.
Santana de Parnaiba
(Brazil), specialized in the production of pressurized solutions and suspensions for inhalation therapy (pMDIs).
Additionally, it has an area dedicated to nasal sprays for the European market.
Santana produces pressurised solutions and suspensions for inhalation therapy (MDI).
In ****, a new investment in
Nerviano
(Italy) has been announced with the construction of a new facility which will be primarily dedicated to manufacturing carbon minimal inhalers (reinforcing the company's commitment to both patients' health and sustainable healthcare solutions), dry powder inhalers and sterile biological products.
Who we are looking for
Purpose
We are looking for a Corporate Quality Auditing Specialist to join our corporate team on a temporary contract.
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 ****:**** 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
Participates 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 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
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
Languages
Good spoken and written English.
Italian, French or Spanish will constitute an important integrative skill.
Soft Skills
Customer orientation
Goal orientation
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 ****:**** regulation
Expertise on pharmaceutical products, sterile products manufacturing and control, biotechnology products.
Preferred Skills
Auditor qualification or QP certification.
ISO ****:**** 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.)
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.
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