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Quality Assurance Specialist CMO

ID:  1495
Date of Posting:  Mar 28, 2025
Business Area:  Quality
Job Type:  Direct Employee
On site / Remote / Hybrid:  Hybrid
Location: 

Milano, IT

Territory: 
Full-Time or Part-Time:  Full Time
Seniority:  Mid-senior

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

La ricerca è rivolta a un candidato o una candidata che abbia maturato una significativa esperienza in ambito di Assicurazione Qualità di azienda farmaceutica, occupandosi di attività attinenti alla Compliance di prodotti e processi con le Buone Pratiche di Fabbricazione e le disposizioni normative applicabili in ambito nazionale ed internazionale, per un periodo di almeno 5 anni. Ambito di applicazione le produzioni realizzate presso terzisti.

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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

Nell’ambito delle competenze maturate, sono ritenute oggetto della selezione quelle legate alla capacità di

  • gestire le attività di convalida di processi;
  • gestire il sistema di controllo delle modifiche;
  • redigere Risk Assessment
  • effettuare indagini e redigere i relativi report;
  • revisionare Metodi/Specifiche Analitiche;
  • gestire le ispezioni da parte di autorità regolatorie e clienti;
  • effettuare audit a fornitori di materie prime e materiali di confezionamento, nonché a terzisti farmaceutici, in Italia ed all’estero;
  • redigere e rivedere Accordi di Qualità.

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Required skills:

  • process validation;
  • change control;
  • Risk Assessment drafting
  • Investigation and related reporting (deviations and/or complaints)
  • Review and manage the flows of the Analitycal methods and specifications;
  • Review and manage the flows of the Master Batch Records;
  • Partecipation to client audit or regulatory inspection
  • carry out audits of suppliers (raw materials, packaging materials and CMO), in Italy and abroad;
  • draft and review Quality Agreements.

Required Education

Laurea in Chimica, Farmacia, Biotecnologie o similari. 

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Degree in Chemistry, Pharmacy, Biotechnology or similar.

Required Skills and Experience

Sono gradite competenze in ambito di dispositivi medici, cosmetici ed integratori alimentari.

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

 

Technical Competencies

E’ richiesta la buona conoscenza di processi di produzione di più forme farmaceutiche; è richiesta in particolare una buona conoscenza dei processi di produzione di forme iniettabili sterili.

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

Required Languages

E’ richiesta la conoscenza della lingua inglese, scritta e orale.

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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.

Apply now »