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:

• SQC Preparation and Publication: Coordinate and prepare monthly SQC slides and summaries, finalize meeting minutes, and publish them in the local DMS system.
• 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.
• Deviation Event Category Limits: Calculate and review deviations to ensure compliance.
• QRM Process: Ensure alignment with global standards, act as a subject matter expert, and resolve PQS internal issues.
• PQS Statistical Tools: Utilize statistical tools for data preparation, extraction, and analysis to support business compliance.
• Quality Metrics Monitoring: Interpret quality metrics and trends to identify risks and deviations, ensuring timely actions are taken.
• Quality Plan Execution: Execute the site quality plan and deliverables, reporting on quality and compliance issues.
• Inspection Readiness: Maintain ongoing inspection readiness, manage remediations, and ensure compliance with GMP and quality processes.
• Continuous Improvement: Identify gaps, implement solutions, and champion innovation to ensure sustainable quality management.
• Training and Awareness: Design, develop, and deliver GMP compliance training and awareness campaigns.
• Change Management: Promote and manage change processes effectively, engaging others and making timely decisions.

Qualifications:

• Education: Minimum BSc in Science or QA discipline.
• Experience: Proven ability to drive performance, excellent decision-making skills, and the ability to meet strict deadlines – in another similar QA role.
• Skills: Strong organizational and planning skills, ability to streamline processes, excellent communication skills, and project management expertise.
• 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!