QA Capital Projects & Aseptic Validation Specialist

BSP Pharmaceuticals S.p.A.; Latina; On-site; EUR 30,000 - 35,000; Full time

Job summary

BSP Pharmaceuticals S.p.A. in Italy invites applications for a QA Capital Projects & Aseptic Processes Specialist.

The role focuses on quality oversight for capital projects and aseptic operations, ensuring compliance with regulatory expectations and company standards. You will conduct risk assessments, prepare validation and cleaning documentation for AIFA submissions, train staff, and support audits as SME.

Qualifications

• Degree in a technical or scientific field.
• Knowledge of pharmaceutical processes.
• Knowledge of analytical methods.
• Knowledge of pharmaceutical legislation and regulations.
• Knowledge of sterile and non-sterile production facilities and aseptic techniques.
• Familiarity with Excel, PowerPoint and MS Project.
• Proficiency in English.
• Strong organizational and interpersonal skills.
• Aptitude for teamwork.

Responsibilities

• Provide quality oversight from the initial project phases through to regulatory authorization.
• Conduct risk assessments in collaboration with operational departments to evaluate, manage, and control critical processes.
• Prepare validation documentation for AIFA submissions and startup.
• Train operational personnel on validation documentation.
• Review URS to ensure machinery and facilities align with procedures and standards.
• Review qualification and validation documentation for equipment and facilities.
• Prepare validation docs for simulated filling processes and coordinate tasks.
• Ensure compliance with company quality standards and procedures.

Skills

Pharmaceutical processes

Analytical methods

English proficiency

Organizational skills

Teamwork

Education

Technical or scientific degree

Tools

Excel

PowerPoint

MS Project

Job description

BSP Pharmaceuticals S.p.A. in Italy invites applications for a QA Capital Projects & Aseptic Processes Specialist.

The role focuses on quality oversight for capital projects and aseptic operations, ensuring compliance with regulatory expectations and company standards. You will conduct risk assessments, prepare validation and cleaning documentation for AIFA submissions, train staff, and support audits as SME.