QA & Validation Specialist - GMP Compliance & Audits

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 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.