Clinical Quality Specialist

ProPharma; Greater London; On-site; GBP 30,000 - 45,000; Full time

Job summary

ProPharma seeks a Quality Specialist in Greater London to ensure compliance with quality standards in Clinical services. The role includes generating reports, analyzing quality deviations, and supporting audits. Candidates should have a university degree and at least 2 years in a Quality Assurance role, alongside knowledge of GxP systems. ProPharma offers an inclusive work environment, emphasizing continuous monitoring to enhance compliance and quality within the organization.

Qualifications

• Maintain compliance with GVP, GCP, and GDP requirements.
• Ability to identify trends and outliers.
• Requires proactive work with minimal supervision.

Responsibilities

• Generate and prepare reports on quality activities.
• Review, approve and communicate corrective actions.
• Track documentation related to quality metrics.
• Support external audits and regulatory inspections.
• Facilitate eQMS activities including document management.

Skills

Knowledge of Good Pharmacovigilance Practices

Excellent computer skills (Microsoft Word, Excel)

Analytical skills

Written and verbal communication skills

Attention to detail

Ability to organize and prioritize

Education

University degree and/or relevant work experience

Job description

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Quality Specialist position supports the delivery of Clinical services, to assure ongoing compliance with quality and industry regulatory requirements. The Quality Specialist performs improvement activities through continuous monitoring and evaluation of the quality system to ensure ongoing maintenance. This position may also support regional and global activities as required.

Main 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
• Collection, management, and analysis of 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 (i.e., Document Management, QA review and approvals, Change Control assessments)

Necessary Skills And Abilities

• Maintains awareness of and ensures compliance with the Good Pharmacovigilance Practices (GVP), Good Clinical Practices (GCP) requirements, and Good Documentation Practices (GDP)
• Works in a professional manner with clients, team members and management. Excellent computer skills including Microsoft Word and Excel
• Analytical skills to gather and interpret data
• Must be able to identify trends and outliers
• Excellent written and verbal communication skills in providing feedback and identifying improvements where needed
• Ability to prioritize and organize the tracking of data, documentation maintenance and record keeping
• Excellent accuracy and attention to detail to ensure all products and services meet standard requirements
• Proactive with the ability to work with minimal supervision

Educational Requirements

• University/bachelor's degree and/or appropriate relevant work experience.

Experience Requirements

• Minimum 2 years of experience working in a Quality Assurance role
• Deviation, CAPA, Effectiveness Check handling experience
• Preferred: Knowledge and experience in working with GxP Quality Management Systems including but not limited to record management, reporting, and data analytics.

We are an Equal Opportunity Employer.