Job Description:
We are recruiting on behalf of a client for a Senior QA Officer on behalf of a client who are a well established Pharma company supplying pharmaceuticals to the NHS and private sectors.
Job Title - Senior Quality Assurance Officer
Sector - Pharma
Location - Birmingham
Salary - to £38,000
Hours - Monday to Thursday 08:00–17:00 and Friday 08:00–12:00
Overview
About the Role
We are seeking an experienced and motivated Senior QA Officer to lead QA GMP tasks within the parallel importing industry. The role will also extend to being cross trained in GDP activities such as supplier/customer qualification, temperature management, and actioning recalls.
This role is critical in ensuring compliance with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and company procedures, while driving continuous improvement across the Quality Management System (QMS).
Key Responsibilities
The key responsibility of this role is to lead GMP Quality Assurance activities, ensuring all operations comply with Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and internal Standard Operating Procedures (SOPs). The post holder will be working closely with the Production Team, QC Team, QPs and RPs and will also play an important role in promoting a strong culture of quality and compliance across the organisation.
The position includes writing and supporting other departments in writing/raising Change Controls, Corrective and Preventive Actions (CAPAs), Deviations, Complaints, and Risk Assessments as well as supporting validation/qualification activities.
A key part of the role is leading investigations into quality issues, ensuring:
* Root causes are clearly identified
* Appropriate CAPAs are implemented
* Actions are monitored to ensure long-term effectiveness
You will also analyse quality data and trends to proactively identify improvements and prevent recurrence of issues.
The role includes responsibility for audits and supplier management, including:
* Conducting internal audits to ensure GMP compliance
* Reviewing audit findings and ensuring timely follow-up actions
* Managing supplier and vendor qualification to maintain quality standards
There may also be opportunities to assist in external audits.
In addition, you will:
* Develop and review SOPs and work instructions
* Ensure document control and archiving processes meet GMP requirements
* Provide staff training in GMP areas
* Provide support and guidance to the production & QC teams
* Foster a culture of continuous improvement and high performance
Candidate Requirements
- Experience in GMP QA
- Strong knowledge of GMP, GDP, and QMS
- Experience with audits, CAPAs, and investigations
- Strong leadership and communication skills
- Have excellent attention to detail