About the Company
A Pharmaceutical manufacturing organisation in the North West
About the Role
The senior QA officer will provide support across QA projects including Validation Activities and QMS in order to ensure business targets are achieved and compliance activities are managed. Work in collaboration with the QMS lead and validation Lead as well as Quality Director.
Responsibilities
* Authoring, review and approval of GxP documentation including batch documentation and SOPs.
* Leading on QMS items as required, including deviations, change controls and temporary process changes (TPCs).
* QMS experience, particularly with internal audits, PQRs, risk assessments, change control, and deviation systems.
* Experience with electronic QMS systems like Q-pulse is a plus, but understanding the process and requirements of quality systems is more crucial.
* Deliver training, i.e. GMP and Data Integrity to Site Personnel.
* Support validation activities, assisting the validation lead as required, author routine protocols and reports for equipment/process validation.
* Support QMS projects, assisting the QMS lead as required.
* Support new product introductions.
* Provide Quality support in manufacturing, packaging operations, warehouse and other areas of the business. This includes being available in the operations areas as required to handle issues in person.
* Providing advice, and instruction as and when necessary to ensure compliance with quality specification.
* Responding proactively to supporting resolution of quality issues.
* Actively raise quality standards and promote a good quality culture across site.
* To perform any other duties that are deemed to be reasonable by Senior Management.
Qualifications
* Bachelor’s degree (or higher) in a relevant scientific discipline
* 1–3+ years of experience working within a GMP-regulated pharmaceutical organisation.
* Experience working within a Quality Management System (QMS), including handling deviations, CAPA, change controls, non-conformances, and document control.
* Familiarity with GMP regulations and guidelines (e.g., EU GMP, MHRA, FDA, ICH) and strong understanding of quality and compliance requirements.
* Experience supporting or conducting internal and external GMP audits, including preparation of audit documentation, participation in audit activities, and tracking corrective actions.
* Experience reviewing quality documentation, including SOPs, batch records, analytical data, validation documentation, and quality records to ensure compliance with GMP and data integrity standards (ALCOA+).
Pay range and compensation package
Salary - £30,000 - £37,000