QAC Specialist

BSP Pharmaceuticals S.p.A.; Latina; On-site; EUR 35,000 - 40,000; Full time

Job summary

BSP Pharmaceuticals S.p.A. is seeking a QAC Specialist to ensure quality during manufacturing of high-potency anticancer drugs. You will investigate process deviations, propose CAPAs, validate processes and support client/regulatory audits in a GMP environment.

The role requires a scientific degree, GMP knowledge, and proven QA experience in multinational pharma. English proficiency is essential, with a salary range of 35K–40K and on-site work in Italy.

Qualifications

• Degree in a scientific discipline (Chemistry, CTF, Pharmacy, Biology).
• GMP & Sterility Assurance knowledge.
• Quality assurance experience in multinational pharmaceutical companies.
• Proficiency in English.

Responsibilities

• Carry out investigations related to deviations from the production process with root-cause analysis and cross-functional collaboration.
• Propose corrective and preventive actions to ensure effective closure of deviations.
• Analyze and evaluate technical documentation related to manufacturing, cleaning and sanitization procedures for validation.
• Support managers in preparation and management of client and regulatory audits.
• Draft Validation Protocols by researching data from other business functions.
• Ensure correct validation of processes and cleaning per company protocols and procedures through execution of activities.
• Prepare Validation Reports.

Skills

GMP & Sterility Assurance knowledge

Quality assurance experience

Proficiency in English

Education

Degree in a scientific discipline

Job description

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.