Qa Specialist LATINA

Qa Specialist
Latina
Lazio, LATINA

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

BSP has been at the forefront in the fight against 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.

Posizione

We are currently looking for a QA Specialist for one of our Quality Assurance Teams, that will mainly ensure:

Deviations and Investigations Management:

Carry out investigations related to deviations from the production process with the aim of identifying their Root Cause through document verification and close cooperation with other departments in compliance with SOPs, current regulations and company quality standards. With the support of the other departments, propose corrective and preventive actions in order to ensure effective closure of deviations in compliance with quality standards and company procedures. Analysis of technical documentation:

Ensure the analysis and evaluation of technical documentation related to manufacturing processes or cleaning and sanitization procedures that have to be submitted for validation. Audit Support:

Support the manager in the preparation and management of client and regulatory Audits. Defining Protocols:

Drafting the Validation Protocols, by researching and acquiring data and information from other business functions. Validation:

Ensure the correct validation of the processes and cleaning in compliance with company protocols and procedures through the execution of the operational activities. Preparation of Validation Reports. Requisiti

MA degree (CTF/Chemistry, etc. . . ) 1-2 years of experience in similar roles in complex organizations Knowledge of GMP English working knowledge Great can-do attitude Altre informazioni

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 diversity, different backgrounds and experiences, and provide equal opportunity for all.

We are BSP.

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