QAC 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. Come for science, stay for purpose. We are currently looking for a QAC Specialist
- that will mainly ensure:
• 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:
• Degree in a scientific discipline (Chemistry, CTF, Pharmacy, Biology)
• GMP& Sterility Assurance knowledge
• Quality assurance experience in multinational pharmaceutical companies
• Proficiency in English Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is: 35K-40K 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.