Quality System Specialist

BSP Pharmaceuticals S.p. A is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxitc characteristics for the Pharmaceuticals Industry.

BSP has been at the forefront in the fight agains cancer since 2006.

Innovation is the hallmark of BSP with investments in new technologies and production methods in a high containment plant.

We are one of the most important Contract Development and Manufacturing Organization (CDMOs) for anticancer drugs.

The fight against cancer is ours too.

We are currently looking for a Quality System Specialist that will mainly ensure :

Contamination Control Strategy (CCS)

Draft, issue and maintain the Contamination Control Strategy Document (CCSD, review documentation associated with CCS, manage and collect CCS metrics data, draft periodic reports, support the Contamination Control Strategy Expert figure in reviewing all plant GMP changes for CCS impact assessment and prepare CCS Quality Questionnaires received from Clients.

Internal/External Audit Area

Support the Manager in the management of internal audits and audits required by customers, in compliance with company quality policies and procedures;

Prepare and support of regulatory inspections, through the collection and provision of all information necessary for the audit, in order to enable the smooth conduct of GMP-regulated activities, in compliance with applicable regulations (laws, European and international GMP standards etc.).

Quality Risk Management Area

Implement and maintain the register of risk assessments carried out in each plant area to ensure their effective validity over time.

Annual Product Quality Review Area

Perform the Annual Product Review and all related activities, trend analysis to support the Management Review in accordance with applicable regulations (laws, European and international GMP standards etc.).

Main Requirements:

• Master's Degree in Chemistry, CTF, Biology, Pharmacy ecc;
• At last 3 years of experience in similar roles in complex organizations
• Advanced knowledge of English;
• Strong analytical skills, business-oriented, client-oriented;
• Great can-do attitude.

If you meet the requirements, apply now. It could be your next step.

At BSP we believe in an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential. We respect the diversity , the different backgrounds and experiences and provide equal opportunity for all.

We are BSP.