Corporate Quality External Manufacturing Snr Specialist - Temporary
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 2024, 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 2025, 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.
Purpose
The ideal candidate will support Corporate Industrial Production Outsourcing Department (Virtual Plant) in Managing CMO’s Quality Activities
Main Responsibilities
- Establish relations with the assigned CMOs to monitor their Quality Management System and ensure appropriateness of operations.
- Actively review and provide productive feedback to CMO on all critical quality issues (deviations, APRs, stability failures, CAPAs, etc.) Review deviations (as per Quality and Technical Agreement) to ensure that they are properly bracketed and investigated and that appropriate CAPAs are implemented.
- Partner with corporate manufacturing technology in assessing the GMP impact of change controls issued either by the CMOs or by Chiesi, ensuring that implementation plan is performed as accurately as requested by corporate.
- Manage product quality complaint investigations from initiation through final approval. Ensuring that complaints – when appropriate – are investigated by CMOs in compliance with cGMPs and that the associated CAPAs are effective.
- Review and report PQRs (APRs) into corporate systems and provide Corporate with appropriate metrics for the corporate quality council.
- Perform review of Certificates of Manufacturing issued by vendors for accuracy.
- Review shipment temperature data to ensure it is within the required specifications.
- Perform review of production/packaging/testing documents according to established procedures. Ensure that production/packaging process follows the approved master documents.
- Perform review of in-process testing worksheets, where applicable, and ensure tests were performed according to the required procedures and that all results are within the established specifications.
- Cooperate with GMD External Manufacturing and Manufacturing technology functions in:
- Due diligence for new CMOs and supervision of quality aspects of their operations
- Support for M&A when requested
- Audit of suppliers and distributors in conjunction with corporate quality systems
- Tech Transfer support
Experience Required
At least 5 years in QC-QA in a GMP-regulated environment with 2 years at least on the company
Education
Bachelor of Science / Community College Diploma in RA/QA /University degree (or equivalent) in Life Sciences or in a related discipline
Languages
Fluent English
Technical Skills
Knowledge of and familiarity with applicable international regulations and Guidelines, in particular the EU, US FDA and Health Canada’s GMPs.
Soft Skills
- Attention to details
- Communication skills
- Customer orientation
- Planning and organizational skills
- Emotional and social intelligence
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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