Senior QC Systems Technical Specialist

Reference Number: JO-2410-542073
Senior QC Systems Technical Specialist
Rate: Negotiable
Job Type: Contract
Location: Hatfield

Overview:
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:

1. Create/maintain master data for QC electronic systems.
2. Support the operation, maintenance, and improvements of the QC electronic systems.
3. Manage change control for qualification/validation compliance.
4. Assist in procuring, deploying, and validating new QC systems, including documentation as per standards.
5. Ensure QC systems supporting manufacturing, packaging, and testing activities comply with SOPs, GMP, and corporate standards.
6. Maintain compliance through collaboration with IT and external support providers.
7. Troubleshoot user/system issues and escalate to QC management as needed.
8. Manage user access and provide training on QC software.
9. Support QC Analysts with software changes following data integrity protocols.
10. Contribute to SOPs, quality policies, training materials, and system documentation.
11. Provide technical responses to global regulatory queries on equipment and methods.
12. Identify and implement continuous improvement initiatives.
13. Advocate for Data Integrity practices and promote best practices within the QC environment.

Skills & Qualifications:

1. 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.
2. Proficient in pharmaceutical QC electronic systems, data integrity principles, and GMP guidelines.
3. Strong technical and scientific judgment with the ability to interpret complex data, analyse user requirements, and implement system improvements.
4. Computer literate (Word, Excel, PowerPoint).
5. Excellent communication and people management skills to support internal and external projects.
6. Skilled at establishing effective working relationships within the organisation, affiliated organisations, and other stakeholders, with the ability to simplify technical information.
7. Keep up-to-date on technical advancements in electronic systems.

If interested, please send your CV to arshaan.sindhwani@cpl.com