14 ott - Latina
BSP Pharmaceuticals
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.
Massimizzi le sue possibilità di successo assicurandosi che il suo CV e le sue competenze corrispondano ai requisiti di questa posizione.
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.
Come for science, stay for purpose.
We are currently looking for a QAC Specialist - that will mainly ensure:
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- 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;
- Ensure the analysis and evaluation of technical documentation related to manufacturing processes or cleaning and sanitization procedures that have to be submitted for validation
- Support the manager in the preparation and management of client and regulatory Audits.
- Drafting the Validation Protocols, by researching and acquiring datas and informations from other business functions;
- Ensure the correct validation of the processes, cleaning in compliance with company protocols and procedures through the execution of the operational activities
- Preparation of Validation Reports
Requirements:
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- Degree in a scientific discipline (Chemistry, CTF, Pharmacy, Biology)
- GMP& Sterility Assurance knowledge
- Quality assurance experience in multinational pharmaceutical companies
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