ProPharma

Clinical Quality Assurance Lead

ProPharma

full-time

Posted on:

Location Type: Hybrid

Location: United Kingdom

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Job Level

Senior

Tech Stack

Google Cloud Platform

About the role

  • Provides guidance for quality activities and drives positive change and process improvement
  • Performs, develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements
  • Host and/or Support CRS/FSP client audit and/or regulatory authority inspection activities
  • Develop responses to CAPAs arising from client/inspections, as applicable to CQA
  • Collaborate with multiple lines of business to prepare for/conduct audits/inspections
  • Support CRS/FSP project leadership in setup and subscription of Client and/or project-specific Deviation, Quality Event, and CAPA eQMS reports for Client provision
  • Conduct periodic review of Deviation, Quality Event, and CAPA eQMS reports to facilitate identification of emerging trends
  • Escalate emerging trends to Management for improvement opportunities

Requirements

  • University/Bachelor’s degree and/or appropriate relevant work experience
  • 5 years’ Quality experience in pharmaceutical or medical device industries or other regulated industries (i.e., healthcare)
  • A minimum of 2 years’ experience hosting GCP audits required
  • Advanced computer skills including experience with Microsoft Office (Outlook, Word, Excel, PowerPoint, Teams, etc.) and Adobe Acrobat application are required
  • Knowledge and experience in working with GxP QMS including but not limited to record management, reporting, and data analytics
  • Excellent verbal, written, presentation skills, and interpersonal communication skills with the ability to establish and sustain professional relationships with clients and internal staff
  • Ability to critically evaluate and troubleshoot complex problems with diligence while integrating stakeholder input and feedback
  • Exceptional time management, project management, delegation, multitasking, decision-making and problem-solving skills
  • Excellent attention to detail and commitment to quality
Benefits
  • Flexibility to adapt and meet fluctuating business priorities
  • Must be willing to travel at least 5%, including internationally
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
quality management processesGCP auditsGxP QMSrecord managementreportingdata analyticsCAPADeviationQuality Eventprocess improvement
Soft Skills
verbal communicationwritten communicationpresentation skillsinterpersonal communicationcritical evaluationproblem-solvingtime managementproject managementdelegationmultitasking