Senior Quality Assurance Specialist - 12 month FTC

Senior Quality Assurance Specialist

Location: Slough, UK

About the Role: Are you passionate about quality and compliance? We are seeking a dedicated Quality Assurance Specialist to join a thriving 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, and publish them in the local DMS system.
2. Deviation Process Management: Represent the site in global meetings, handle communication, and address questions related to deviations, audit observations, and CAPAs. Provide strategic expertise and resolve escalated PQS internal issues.
3. Deviation Event Category Limits: Calculate and review deviations to ensure compliance.
4. QRM Process: Ensure alignment with global standards, act as a subject matter expert, and resolve PQS internal issues.
5. PQS Statistical Tools: Utilize statistical tools for data preparation, extraction, and analysis to support business compliance.
6. Quality Metrics Monitoring: Interpret quality metrics and trends to identify risks and deviations, ensuring timely actions are taken.
7. Quality Plan Execution: Execute the site quality plan and deliverables, reporting on quality and compliance issues.
8. Inspection Readiness: Maintain ongoing inspection readiness, manage remediations, and ensure compliance with GMP and quality processes.
9. Continuous Improvement: Identify gaps, implement solutions, and champion innovation to 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, engaging others and making timely decisions.

Qualifications:

1. Education: Minimum BSc in Science or QA discipline.
2. Experience: Proven ability to drive performance, excellent decision-making skills, and the ability to meet strict deadlines – in another similar QA role.
3. Skills: Strong organizational and planning skills, ability to streamline processes, excellent communication skills, and project management expertise.
4. Attributes: Open-minded, enthusiastic, collaborative, and a 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!

Apply Now to join this team and take the next step in your career!