QAC Specialist - Investigation

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 Contract Development and Manufacturing Organization (CDMO).The BSP campus hosts 2 segregated facilities to serve the clients with development from pre-clinical GLP to cGMP manufacturing for clinical and commercial supply of Cytotoxic and High Potent Oncology drugs and Non-Cytotoxic, innovative compounds for Immunotherapy and other therapeutics applications.Facilities designed to handle small and large molecules as ADCs (conjugation and fill finish), Peptides, Proteins, Oligonucleotides and Nano Medicines.BSP is technologically developed to meet the needs of innovators, with its High Containment Facility designed to offer a full range of integrated services aimed to support the entire life cycle of a product, from the formulation and process development/optimization, through scale up/scale down studies

Activities

• 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

Requisiti

• MA degree (CTF/Chemistry, etc...)
• English working knowledge
• Great can‑do attitude