QA GDP Specialist - Temporary
Parma, IT
About us
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 (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 have been awarded with 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); Blois-La Chaussée-Saint-Victor (France); Santana de Parnaíba (Brazil). The plants produce a total of over 110 million units per year.
The production plant in Parma covers a total area of more than fifteen thousand square meters and it is the strategic hub for the production and distribution of our products, being an international supply center that exports to more than 80 countries. The Parma plant produces solid medicinal products, such as tablets and inhaled dry powders; inhalation solutions and suspensions, either pressurized or sterile single-dose vials; vials of sterile suspension for endotracheal administration; liquid forms such as drops, syrups and nasal sprays.
Santana produces pressurized solutions and suspensions for inhalant therapy (MDIs) and supplies both domestic market and Group’s Affiliates and exports to licensees and distributors. Blois specializes in Dry Powder Inhalers and final assembly stages of the Metered-Dose Inhalers (MDIs), supplies Group’s Affiliates and distributes directly to clients at a local level and in export markets.
Who we are looking for
Main Responsibilities
• Support maintenance of Quality Systems in line with best practice standards and GDP requirements including but not limited to deviations, CAPA, change control / management, audits, customer distribution complaints, supplier qualification, customer / wholesaler Bona Fide approval, Quality and Technical Agreements with customers / suppliers, Shipping / Transportation validation.
• Develop and review quality documentation and procedures as requested.
• Implement and manage training on GDP and QMS documentation.
• Assist with preparation of status report metrics for deviations, CAPAs and Change Control/Management systems and other relevant KPIs.
• Assist with investigations and management of the implementation and maintenance of Corrective Action Preventative Action.
• Ensure Quality risk management documentation is complete and maintained and assist with administration of the records retention programme.
• Participate to regulatory inspections and customer audits as required.
• Ensure that initial and continuous training programmes for all personnel involved in GDP/distribution activities for Medicinal Products and Active Substances are implemented and maintained.
• Ensure that relevant customer distribution complaints are dealt with effectively.
• Review of temperature excursions and evaluation the subsequent suitability of the Product for use.
Experience Required
Previous experience in a similar role within the pharmaceutical industry
Education
Bachelor or Master's Degree in scientific disciplines
Languages
Fluent English (both written and spoken)
Technical Skills
• Knowledge of Quality standards and Regulatory guidelines and requirements relating to pharmaceutical and/or biotech products;
• Demonstrated skills and experience in the conduct of Quality activities as described above.
Soft Skills
- Analytical skills
- Problem solving
- Planning and organizational skills
- Time management
- Continuous learning
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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