QA Capital Projects & Aseptic Processes 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 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 QA Capital Projects & Aseptic Processes Specialist

Main activities :

Qualification and Validation:

• 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 process validation documentation (including the Master File) and cleaning validation documentation required for AIFA (Italian Medicines Agency) submissions and subsequent operational startup.
• Train operational personnel on the execution and completion of validation documentation issued by the team.
• Review project User Requirement Specifications (URS) to ensure that the construction of machinery and facilities aligns with company procedures and standards.
• Review qualification and validation documentation for equipment and facilities.
• Prepare validation documentation for simulated filling processes in compliance with company protocols and procedures, by executing the operational activities defined in the protocols and coordinating/supervising the tasks performed by other company functions.
• Ensure adherence to company quality standards by applying procedures relevant to the area of responsibility, in compliance with corporate quality policies and procedures, as well as applicable regulations.

Audits:

• Collaborate with the department manager to prepare for and support audits and inspections by external bodies, acting as a Subject Matter Expert (SME).

Safety:

• Regarding EHS (Environment, Health, and Safety) obligations and responsibilities, please refer to the provisions of Article 20 of Legislative Decree 81/08 (and subsequent amendments) - "Obligations of Workers."

Main requirements:

• Degree in a technical or scientific field
• Knowledge of pharmaceutical processes
• Knowledge of analytical methods,
• Knowledge of pharmaceutical legislation, national/international regulations,
• Knowledge of pharmaceutical production facilities and processes (both sterile and non-sterile) and aseptic techniques
• Familiarity with key software tools (Excel, PowerPoint, MS Project)
• Proficiency in english language
• Strong organizational and interpersonal skills
• Aptitude for teamwork

Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is :

Temporary Contract - 30-35k

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