QA/QC Specialist: GMP Validation & Deviation Management

BSP Pharmaceuticals S.r.l.; Latina; On-site; EUR 35,000 - 55,000; Full time

Job summary

BSP Pharmaceuticals S.p.A. is a CDMO offering development and manufacturing services for cytotoxic and non-cytotoxic therapies. The role supports deviation investigations, CAPA implementation, validation activities, and audit readiness within a regulated environment.

Responsibilities include preparing validation protocols and reports, collaborating with cross-functional teams, and ensuring compliance with SOPs and regulatory standards during manufacturing and cleaning validations.

Qualifications

• MA degree in Chemistry or related field.
• English working knowledge.
• Great can-do attitude.

Responsibilities

• Carry out investigations related to deviations from the production process and identify root causes in collaboration with other departments.
• Propose corrective and preventive actions to ensure effective closure of deviations in compliance with quality standards.
• Evaluate manufacturing process documentation and cleaning validation data for validation submissions and audits.
• Draft Validation Protocols by gathering data from other business functions.
• Ensure validation of processes and cleaning per company protocols through execution of operational activities.
• Prepare Validation Reports.

Skills

English working knowledge

Can-do attitude

Education

MA degree (CTF/Chemistry, etc...)

Job description

BSP Pharmaceuticals S.p.A. is a CDMO offering development and manufacturing services for cytotoxic and non-cytotoxic therapies. The role supports deviation investigations, CAPA implementation, validation activities, and audit readiness within a regulated environment.

Responsibilities include preparing validation protocols and reports, collaborating with cross-functional teams, and ensuring compliance with SOPs and regulatory standards during manufacturing and cleaning validations.