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.