Overview
Quality Assurance Specialist Jobs in Reading, England, United Kingdom at TieTalent
Title: Quality Assurance Specialist
Company: TieTalent
Location: Reading, England, United Kingdom
About
Quality Assurance Specialist
We are seeking a dedicated and experienced Quality Assurance Specialist to support operations ensuring compliance with Good Manufacturing Practices (GMP) and manage GMP issues through Quality Management System (QMS) processes, site governance, and senior QA leadership.
Key Responsibilities
Compliance Support: Ensure operations comply with GMP standards.
GMP Issue Management: Manage and support GMP issues through QMS processes, site governance, and senior QA leadership.
Quality Processes: Implement, manage, and enforce quality processes on site.
Continuous Improvement: Support senior QA leadership to drive continuous improvement and maintain compliance with regulatory authorities, global quality standards, and customer expectations.
Quality Records Management: Provide review, approval, and support for the management of quality records (e.g., Deviations, CAPA, Change Controls, Investigations, OOS).
Compliance Issue Escalation: Manage and escalate major and critical compliance issues through site QMS processes.
Audit Readiness: Maintain and promote a state of audit readiness.
Process Improvement Initiatives: Suggest, initiate, participate, and contribute to PQS process improvement initiatives and projects.
QA SME Support: Provide QA SME support at departmental Local Quality Councils, project meetings, and during out-of-hours manufacturing.
Qualifications:
Proven experience in GMP compliance and quality assurance.
Strong knowledge of GMP and quality processes.
Excellent problem-solving and analytical skills.
Strong communication and teamwork abilities.
Ability to mentor and coach others in cGMP practices.
Proactive and independent working style.
Previous experience as QA approver of Deviations, CAPAs, Change Controls is essential.
Nice-to-have skills
Process Improvement
Reading, England
Work experience
QA
QA Test Automation
QA Manual Test
Languages
English
