Siemens Quality Assurance Manager & Qualified Person 

Italy, Lombardy, Milan 

4278732

Apply now for the position ofQuality Assurance Manager & Qualified Personin Colleretto Giacosa, Turin, and you will be in charge of the maintenance at local level of the quality management system as per GMP regulation and corporate guidelines as well as of all health regulated activities ensuring that all the relevant external and internal requirements are implemented, monitored for performance and adherence.As Qualified Person you will release batches of pharmaceutical products for human use in accordance with the relevant requirements and the European Union pharmaceutical regulation (Directive 2001/83/EC for Medicinal products for human use).

Your role:

• You Maintain and supervise the local quality system as per GMPs and corporate guidelines.
• You ensure that out of specifications, out of trend, deviations, CAPA, change controls are addressed and recorded according to cGMP and SOPs.
• You assure the application of the recall procedure in case of critical issues impacting the products as per GMPs and Health Authorities (AIFA and FDA) requirements.
• You release the batches of radiopharmaceuticals produced according to Directive 2001/83/EC for Medicinal products for human use and National laws.
• You certify the production operations on suitable documentation and have responsibility for their conservation/updating.

Your expertise:

Bachelor’s degree in Scientific field (e.g. chemistry, pharmacy, engineering, biology).

3+ years of experience in the radiopharmaceutical field or in a pharmaceutical company.

Ministerial Qualification as a Qualified Person.

Good knowledge of English.