LES GxP Lab Project Specialist

Join Our Team as a LES GxP Lab Project Specialist!

Are you a seasoned professional with a knack for managing and executing projects in GxP-regulated laboratory environments?

Proclinical is seeking a dedicated and experienced professional to fill the role of LES GxP Lab Project Specialist. We are urgently looking for a dynamic individual to lead the implementation of data integrity and compliance measures within our lab systems. This role blends laboratory expertise with IT proficiency to ensure seamless project planning and execution, while providing top-tier support for analytical instruments and software.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• Project Planning & Execution: Independently plan and execute activities related to data integrity and compliance in a GxP lab setting.
• Advanced Support: Offer 2nd and 3rd level support for analytical instrument applications and software, resolving issues like network problems, license configurations, and data flow/storage challenges.
• Incident Resolution: Diagnose and resolve hardware, software, and network issues using established analytical techniques.
• User Administration: Manage user accounts, including creation, access control, and regular validation checks.
• Maintenance & Reviews: Assist with periodic reviews and maintenance tasks, ensuring adherence to maintenance plans, supporting firmware updates, and collaborating with instrument owners.
• System Configuration & Compliance: Set up, configure, troubleshoot, and maintain quality systems in QC and manufacturing labs, ensuring compliance with FDA standards and industry best practices, particularly CFR 21 Part 11 and EU Annex 11 regulations.

Requirements:

• Education: University degree in a related field or equivalent experience, with at least 5 years of hands-on experience in a GxP-regulated environment.
• Regulatory Knowledge:
  • Understanding of the GAMP 5 framework.
  • Familiarity with FDA CFR21 Part 11 & EU Annex 11 regulations.
  • Knowledge of USP 1058 guidelines.
  • Experience with Computer System Validation (CSV) methods.
• Technical Skills:
  • Proficiency with Windows XP, 7, 10, Server 2008, 2012, 2016, Active Directory, storage and backup devices, VMware, routers, and switches.
  • Knowledge of server, storage, and virtualization standards, techniques, and tools.
  • Experience with standard software packages, including Microsoft Office and Adobe productivity tools.
• Collaboration & Communication: Ability to work effectively with peers, cross-functional teams, and users across the organization to achieve high product and process quality.
• Analytical & Problem-Solving: Strong analytical, problem-solving, and organizational skills.
• Language Skills: Fluency in written and verbal communication in both German and English.

If you are passionate about ensuring data integrity and compliance in a GxP-regulated environment and have the technical skills to back it up, we would love to hear from you!

Apply now to make a significant impact.

For any questions, please reach out to e.pretorius@proclinical.com

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, 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.