Senior Quality Assurance Specialist
Location: Slough, UK
About the Role:
We are seeking a dedicated Quality Assurance Specialist to join our team. In this senior role, you will be the go-to expert for quality matters on site, ensuring that processes align with global standards and regulatory requirements.
Key Responsibilities:
1. SQC Preparation and Publication:
* Coordinate and prepare monthly SQC slides and summaries.
* Finalize meeting minutes.
* Publish them in the local DMS system.
2. Deviation Process Management:
* Represent the site in global meetings.
* Handle communication.
* Address questions related to deviations, audit observations, and CAPAs.
* Provide strategic expertise.
* Resolve escalated PQS internal issues.
3. Deviation Event Category Limits:
* Calculate and review deviations to ensure compliance.
4. QRM Process:
* Evaluate alignment with global standards.
* Act as a subject matter expert.
* Resolve PQS internal issues.
5. PQS Statistical Tools:
* Utilize statistical tools for data preparation, extraction, and analysis.
* Support business compliance.
6. Quality Metrics Monitoring:
* Interpret quality metrics and trends.
* Identify risks and deviations.
* Ensure timely actions are taken.
7. Quality Plan Execution:
8. Inspection Readiness:
* Maintain ongoing inspection readiness.
* Manage remediations.
* Ensure compliance with GMP and quality processes.
9. Continuous Improvement:
* Identify gaps.
* Implement solutions.
* Champion innovation.
* Ensure sustainable quality management.
10. Training and Awareness:
* Design, develop, and deliver GMP compliance training and awareness campaigns.
11. Change Management:
* Promote and manage change processes effectively.
* Engage others.
* Make timely decisions.
Qualifications:
12. Education:
* Minimum BSc in Science or QA discipline.
13. Experience:
* Proven ability to drive performance.
* Excellent decision-making skills.
* Ability to meet strict deadlines – in another similar QA role.
14. Skills:
* Strong organizational and planning skills.
* Ability to streamline processes.
* Excellent communication skills.
* Project management expertise.
15. Attributes:
* Open-minded.
* Enthusiastic.
* Collaborative.
* Champion of diversity and quality concepts.
Why This Role?
* Be part of a dynamic team that values innovation and continuous improvement.
* Opportunity to make a significant impact on our quality processes and compliance.
* Collaborative and inclusive work environment.
If you are a proactive problem-solver with a passion for quality and compliance, we would love to hear from you.