Quality IT Systems Analyst – GMP, LIMS & CDS

Proclinical Group; Hatfield; On-site; GBP 50,000 - 75,000; Full time

Job summary

Proclinical Group is seeking a dedicated Quality Analyst to support the digital transformation journey of a manufacturing site, focusing on implementing and maintaining IT systems that align with GMP regulations. This role will primarily involve working with Quality Systems such as LIMS, CDS, and other QC equipment applications, while also supporting broader manufacturing IT needs.

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

Qualifications

• Background in computer science, information systems, or equivalent experience in a regulated environment.
• Experience supporting pharmaceutical quality and manufacturing systems.
• Knowledge of system lifecycle management and computer systems validation (CSV), preferably GAMP5.
• Hands-on experience with LIMS, CDS, and Quality Systems.
• Familiarity with ITILv4 and project management principles.

Responsibilities

• Implement and maintain IT systems and processes in line with GMP regulations, focusing on Quality Systems (e.g., LIMS, CDS, QC equipment applications).
• Provide day-to-day IT support, including issue resolution, system changes, and service optimization.
• Manage IT requests via the ticketing system and ensure timely responses.
• Facilitate deviation and CAPA management, ensuring regulatory compliance and continuous improvement.
• Author and update validation documentation, IT data processes, and other compliance-related materials.
• Support audits and inspections related to IT quality and regulatory compliance.
• Collect business requirements and translate them into solution specifications.
• Participate in application design discussions and ensure adherence to established standards.
• Lead or support validation activities for IT systems and software applications.
• Conduct testing and implementation of new applications, ensuring cybersecurity compliance.
• Identify opportunities for process improvements and implement strategic changes to enhance operational efficiency.
• Stay updated on industry trends, regulatory changes, and best practices related to Quality Systems and Smart Labs.
• Contribute to smart factory initiatives and collaborate with other teams as needed.

Skills

GAMP5

CSV

Problem solving

Communication skills

Regulatory compliance

Project management

Collaboration

Self-starter

Education

Bachelor's degree in Computer Science or Information Systems

Tools

LIMS

CDS

Quality Systems

Job description

Proclinical Group is seeking a dedicated Quality Analyst to support the digital transformation journey of a manufacturing site, focusing on implementing and maintaining IT systems that align with GMP regulations. This role will primarily involve working with Quality Systems such as LIMS, CDS, and other QC equipment applications, while also supporting broader manufacturing IT needs.

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