Quality Assurance Specialist CMO

With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We've always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest - we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow - with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.

Job Purpose

We are looking for a candidate with an experience of at least 5 years in the Quality Assurance of a pharmaceutical company to manage third party production.

Key Responsibilities

1. Gestire le attività di convalida di processi;
2. Gestire il sistema di controllo delle modifiche;
3. Redigere Risk Assessment;
4. Effettuare indagini e redigere i relativi report;
5. Revisionare Metodi/Specifiche Analitiche;
6. Gestire le ispezioni da parte di autorità regolatorie e clienti;
7. Effettuare audit a fornitori di materie prime e materiali di confezionamento, nonché a terzisti farmaceutici, in Italia ed all'estero;
8. Redigere e rivedere Accordi di Qualità.

Required Skills

1. Process validation;
2. Change control;
3. Risk Assessment drafting;
4. Investigation and related reporting (deviations and/or complaints);
5. Review and manage the flows of the Analytical methods and specifications;
6. Review and manage the flows of the Master Batch Records;
7. Participation to client audit or regulatory inspection;
8. Carry out audits of suppliers (raw materials, packaging materials and CMO), in Italy and abroad;
9. Draft and review Quality Agreements.

Required Education

Degree in Chemistry, Pharmacy, Biotechnology or similar.

Required Skills and Experience

Skills in medical devices, cosmetics and food supplements are welcome.

Technical Competencies

Good knowledge of multiple pharmaceutical forms production processes is appreciated; in particular, a good knowledge of the sterile injectable forms is required.

Required Languages

Knowledge of the English language, written and oral, is required.

Travel required in %

At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.