GMP QA Document Controller & eQMS Specialist

Cardiff and Vale University Health Board

Seaton Delaval

On-site

GBP 21,000 - 32,000

Full time

5 days ago

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Job summary

The Medicines Manufacturing Centre (MMC) is a brand-new NHS pharmaceutical production facility located at the Northumbria Innovation and Manufacturing Hub in Seaton Delaval, Northumberland. It operates under MHRA, GMP, and GDP standards and aims to supply Ready-to-Administer medicines with regional impact.

This role provides QA administration to support compliance, document management, and training material updates.

Qualifications

NVQ Level 3 Science Manufacturing Technician or equivalent qualification.
Knowledge of organisational policies and procedures and experience with non-routine issues.
Experience working in a regulated environment.
Coaching and mentoring practices and tools knowledge.
Knowledge of quality improvement tools and methods.
Experience performing audits and recording findings.

Responsibilities

Contribute to GMP-compliant manufacturing facility delivery to optimise regional benefit.
Support QA activities for products and processes under the MMC's MS Licence, ensuring MHRA/NHS standards compliance.
Provide administrative QA resource to support GMP compliance at the MMC and manage the eQMS document management module.
Manage document storage, archiving, and paper/hybrid document workflows with training forms and validation protocols.
Collaborate with the QA Computerised Systems Validator to execute validation protocols and address data integrity issues.
Set up and maintain the Asset, Supplier and Audit modules on the eQMS, updating records and supporting related processes.
Support PQS modules (CAPA, I&O) and assist with training material updates and complaints handling.