Senior QC Systems Specialist—LIMS/CDS & GMP Compliance

Proclinical; England; Sur place; GBP 45 000 - 65 000; Plein temps

Résumé du poste

Proclinical is seeking a Senior QC Systems Technical Specialist to join our client's team. You will provide technical support for laboratory electronic systems including LIMS and CDS, ensuring GMP compliance and data integrity.

Responsibilities include master data maintenance, system qualification/validation, investigations, SOPs, change control, and stakeholder collaboration across functions and external partners.

Qualifications

• Degree or equivalent in a scientific discipline.
• Strong working knowledge of QC laboratory electronic systems and their qualification and validation requirements.
• Demonstrable experience creating and maintaining master data within LIMS and/or CDS platforms in a regulated pharmaceutical environment.
• Experience using QC electronic systems as an end user.
• Strong understanding of GMP requirements and data integrity principles.
• Ability to analyse business and user requirements to support system enhancements and process improvements.
• Excellent communication and stakeholder management skills.
• Ability to establish effective working relationships across multiple functions and external partners.
• Sound technical and scientific judgement.
• Experience interpreting complex data and communicating findings clearly.
• Ability to explain technical concepts in a clear and practical manner.
• Proficient in Microsoft Word, Excel and PowerPoint.
• Highly organised, detail-oriented and capable of working independently.
• Strong problem-solving, decision-making and time-management abilities.
• Commitment to remaining current with developments in laboratory and electronic systems technologies.

Responsabilités

• Maintain and update master data for QC electronic systems.
• Provide technical support for the operation, maintenance and continuous improvement of laboratory systems.
• Support the deployment, validation and qualification of new or upgraded systems.
• Generate, review and maintain qualification and validation documentation.
• Assist with system investigations, troubleshooting and issue resolution.
• Develop and maintain SOPs, work instructions and training materials.
• Support change control processes and system lifecycle management activities.
• Respond to regulatory and compliance-related requests concerning laboratory systems, equipment and methods.
• Identify opportunities to improve system performance, compliance and user experience.
• Champion data integrity principles and electronic system best practices.

Connaissances

GMP & data integrity

Lab electronic systems knowledge

LIMS/CDS master data management

End-user system operation

Stakeholder management

Communication

Analytical thinking

Technical/scientific judgement

Documentation & SOP skills

Formation

Degree in a scientific discipline

Outils

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Description du poste

Proclinical is seeking a Senior QC Systems Technical Specialist to join our client's team. You will provide technical support for laboratory electronic systems including LIMS and CDS, ensuring GMP compliance and data integrity.

Responsibilities include master data maintenance, system qualification/validation, investigations, SOPs, change control, and stakeholder collaboration across functions and external partners.