Senior Quality Assurance Officer
Pharmaceutical Manufacturing & Distribution
GMP | QMS | Validation | Deviations | CAPA | Audit Readiness
I am partnered with a regulated pharmaceutical organisation seeking a Senior Quality Assurance Officer to support site-wide GMP compliance, validation activities and QMS improvement initiatives.
This is a highly visible, operational role offering direct exposure across manufacturing and warehouse functions. The successful candidate will also deputise for the QA Lead when required, providing valuable leadership development opportunities.
The Role
As part of the Quality team, you will:
* Support equipment, utility and process validation activities, including authoring and reviewing validation protocols and reports
* Lead and manage QMS processes including deviations, CAPAs, change controls and temporary process changes
* Author, review and approve GxP documentation including batch manufacturing records and SOPs
* Support regulatory and customer audits, acting as a Quality representative as required
* Conduct internal audits across manufacturing and warehouse operations
* Deliver GMP and Data Integrity training to site personnel
* Provide shop floor Quality oversight, supporting real-time resolution of quality issues
* Support new product introductions, ensuring compliance throughout transfer and launch
* Contribute to QMS projects and continuous improvement initiatives
* Promote and embed a strong quality culture across site.
Experience Required
* Quality experience within pharmaceutical manufacturing / operations
* Strong working knowledge of EU GMP and Data Integrity principles
* Practical experience managing deviations, CAPAs and change controls
* Exposure to validation documentation and lifecycle activities
* Experience supporting audits or regulatory inspections (MHRA/FDA desirable)
* Strong cross-functional communication skills