Do you thrive on ensuring every system meets rigorous validation standards while empowering a CMO's vision?

Proclinical is seeking a QA CSV Specialist to support the validation and lifecycle management of computerized systems within a regulated environment. This role focuses on implementing industry best practices in alignment with GAMP regulations, driving process improvements, and providing technical guidance for compliance. You will work closely with cross-functional teams to ensure operational efficiency and regulatory adherence.

Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.

Responsibilities:

• Act as a liaison between QA CSV and internal/external stakeholders.
• Monitor industry regulations and trends to optimize policies and procedures.
• Oversee validation and lifecycle management of computerized systems, including process control systems, MES, Delta V, spreadsheets, and bench-top equipment.
• Provide expert IT guidance for GMP decisions related to computerized systems.
• Implement continuous improvement initiatives and develop local Validation Plans and Master Plans.
• Manage system lifecycle deliverables from commissioning and qualification to system retirement.
• Ensure compliance with regulatory requirements such as GMP Annex 11, 21 CFR, GAMP, and PICS.
• Develop project scopes, implementation plans, and tracking mechanisms while proactively addressing potential roadblocks.
• Audit projects and systems to verify appropriate validation activities and compliance.
• Collaborate with engineering, automation, and operations teams to evaluate new applications and identify validation requirements.
• Represent or support the QA CSV Manager on CSV-related issues to address GMP concerns effectively.

Key Skills and Requirements:

• Bachelor's degree in Engineering, Information Technologies, Natural Sciences, or a related field.
• Proficiency in English; knowledge of German is an advantage.
• Strong understanding of system lifecycle deliverables and regulatory requirements (e.g., GMP Annex 11, 21 CFR, GAMP, PICS).
• Experience in project management, including developing project scopes, plans, and tracking mechanisms.
• Ability to identify and implement process improvements to enhance efficiency and compliance.
• Familiarity with computerized systems such as MES, Delta V, and process control systems.
• Strong communication and collaboration skills to work effectively with cross-functional teams.
  

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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