Quality Specialist

4 weeks ago

United Kingdom ProPharma Full time

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. As the world’s largest RCO (Research Consulting Organization), 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 Medical Information 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. Retrospectively evaluates telephone skills and case reports to ensure compliance standards are met and maintained.
Generate and prepare reports to communicate outcomes of quality activities.
Analyze and investigate, Deviations and Quality Events to identify areas for improvement in the quality system.
Collection, management, and analysis of data related to CAPAs, Deviations and quality KPIs.
Support the Quality Manager during external client audits or regulatory inspections by creating reports, gathering documents, and supplying requested data.
Perform effectiveness checks on Deviations and Quality Events to determine efficacy of CAPAs.
In conjunction with the Quality Manager, conducts routine Pharmacovigilance audits.
Document Management, QA review and approvals, Change Control assessments, etc.)
Excellent computer skills including Microsoft Word and Excel.
Analytical skills to gather and interpret data. Ability to prioritize and organize the tracking of data, documentation maintenance and record keeping.
University/Bachelor’s degree and/or or appropriate relevant work experience.
~2 years’ experience working in a Quality Assurance role ideally linked to Medical Information or Pharmacovigilance services would be highly preferable
~ Experience of with assessing telephone calls in a call center is preferred.
~ Quality or Six Sigma Certifications are an advantage.


We are committed to diversity, equity, and inclusion. Please, no phone calls or emails***

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