Clinical Quality & CAPA Specialist

3M HEALTHCARE; York and North Yorkshire; On-site; GBP 32,000 - 46,000; Full time

Job summary

ProPharma is seeking a Quality Specialist to support Clinical services, ensuring ongoing compliance with quality and regulatory requirements across the lifecycle. You will monitor quality systems, investigate deviations, and implement corrective actions, contributing to audits and inspections.

Ideal candidates have a Bachelor's degree with at least 2 years in QA, experience with CAPA/Deviations, and strong data analytics, communication, and documentation skills to drive continuous improvement in

Qualifications

• Bachelor's degree and/or relevant work experience in quality assurance.
• Minimum 2 years of experience working in a Quality Assurance role.
• Experience with Deviation, CAPA, and Effectiveness Check handling.
• Knowledge and experience with GxP Quality Management Systems, including record management, reporting, and data analytics.

Responsibilities

• Generates and prepares reports to communicate outcomes of quality activities.
• Analyzes and investigates Deviations and Quality Events to identify areas for improvement in the quality system.
• Reviews, approves, and communicates root cause and corrective action to stakeholders.
• Develops, recommends, and monitors corrective and preventive actions.
• Tracks documentation, as necessary.
• Collects, manages, and analyzes data related to CAPAs, Deviations, and quality KPIs.
• Records, tracks, and trends audit findings and response times.
• Supports external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.
• Performs effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.
• Supports and facilitates eQMS activities (e.g., Document Management, QA review and approvals, Change Control assessments).

Skills

GVP knowledge

GCP knowledge

GDP knowledge

Data analysis

Attention to detail

Communication skills

MS Excel

MS Word

Education

Bachelor's degree

Tools

Microsoft Word

Excel

Job description

ProPharma is seeking a Quality Specialist to support Clinical services, ensuring ongoing compliance with quality and regulatory requirements across the lifecycle. You will monitor quality systems, investigate deviations, and implement corrective actions, contributing to audits and inspections.

Ideal candidates have a Bachelor's degree with at least 2 years in QA, experience with CAPA/Deviations, and strong data analytics, communication, and documentation skills to drive continuous improvement in