Quality Information System Analyst

Ready to lead quality analysis that helps bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a difference!

Proclinical is recruiting for 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. You will collaborate with cross‑functional teams, including business stakeholders, IT colleagues, and external vendors, to deliver effective solutions and ensure ongoing system compliance and optimization.

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

• 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.

Key Skills and Requirements

• 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.
• Proficiency in SQL, data management, and analytics is advantageous.
• Strong problem‑solving skills and attention to detail.
• Excellent communication skills, with the ability to explain technical concepts to non‑technical colleagues.
• Collaborative mindset and willingness to work closely with Quality and other business teams.
• Self‑starter with the ability to manage multiple projects simultaneously.

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