Qualification Supervisor LATINA

Qualification Supervisor
Latina
Lazio, LATINA

Descrizione azienda**:

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.

**Posizione**:

We are currently looking for a _Qualification Supervisor - _that will mainly ensure:

- Ensure the conduct of Qualifications in accordance with Qualification plans, managing the internal working group and external resources;

- Ensure the proper drafting of Qualification Protocols (DQ-IQ-OQ-PQ), Validation Reports (VR), Validation Master Plan (VMP), Validation Plan (VP), Risk Assessment (RA), and all Departmental documentation in accordance with plant SOPs;

- Ensure data analysis activities related to Qualification activities;

- In collaboration with the purchasing function, supervise the formulation of bid requests to suppliers and the preparation of technical/economic analysis of bids received and support the definition phase of commercial negotiations;

- Define with team support the qualification strategy for machines/equipment;

- Coordinate the preparation, submission of documentation and resolution of any observations arising during regulatory and customer audits;

- Monitor the execution of training of departmental personnel and external consultants in accordance with company procedures;

- Ensure the continuous updating of departmental operating procedures;

- Manage the preparation of departmental documentation required by business functions;

- Monitor the management and maintenance of the Plant Equipment/Plant Document Archive;

- Monitor the management and maintenance of electronic documentation (e. g. , parameter database) of each qualified equipment/plant.

**Requisiti**:

- Master's Degree in Chemical Engineering/CTF/Chemistry;

- Knowledge of regulations regarding Equipment and Utilities validation, with particular reference to sterile departments;

- At least 5 years of experience in the qualification/validation role in complex organizations;

- English;

- Can-do attitude;

- Client Oriented.

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

- We are BSP. _