Senior QC Systems Technical Specialist
Hatfield
12-month FTC
Negotiable Salary
Cpl Life Sciences are partnering with a global pharmaceutical company to support QC laboratory electronic systems (e.g., LIMS, CDS) as a Senior QC Systems Technical Specialist, this role involves maintaining master data, troubleshooting issues, implementing system improvements, and ensuring compliance with SOPs, GMP, and Data Integrity guidelines.
Key Responsibilities:
- Create/maintain master data for QC electronic systems.
- Support the operation, maintenance, and improvements of the QC electronic systems.
- Manage change control for qualification/validation compliance.
- Assist in procuring, deploying, and validating new QC systems, including documentation as per standards.
- Ensure QC systems supporting manufacturing, packaging, and testing activities comply with SOPs, GMP, and corporate standards.
- Maintain compliance through collaboration with IT and external support providers.
- Troubleshoot user/system issues and escalate to QC management as needed.
- Manage user access and provide training on QC software.
- Support QC Analysts with software changes following data integrity protocols.
- Contribute to SOPs, quality policies, training materials, and system documentation.
- Provide technical responses to global regulatory queries on equipment and methods.
- Identify and implement continuous improvement initiatives.
- Advocate for Data Integrity practices and promote best practices within the QC environment.
Skills & Qualifications:
- Degree in a science discipline or equivalent experience, with at least two years of experience managing master data in pharmaceutical LIMS/CDS systems, and solid familiarity with QC electronic systems, including their qualification, validation, and end-user perspective.
- Proficient in pharmaceutical QC electronic systems, data integrity principles, and GMP guidelines.
- Strong technical and scientific judgment with the ability to interpret complex data, analyse user requirements, and implement system improvements.
- Computer literate (Word, Excel, PowerPoint).
- Excellent communication and people management skills to support internal and external projects.
- Skilled at establishing effective working relationships within the organisation, affiliated organisations, and other stakeholders, with the ability to simplify technical information.
- Keep up-to-date on technical advancements in electronic systems.
If interested, please send your CV to