42 applicants

Company

ICON plc · 3 days ago

Senior QA Auditor - Client Audit Management

Sofia, NM

Full-time

Remote

Senior Level

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Pharmaceutical Manufacturing

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Responsibilities

Leading and supporting external audits of ICON including scheduling, preparation and hosting.

Leading CAPA management for external audits of ICON and/or investigator sites, where needed, in order to assure responses are compliant with ICON or Sponsor SOP requirements.

Leading CAPA management for sponsor audits of ICON, including liaising with ICON operation teams to ensure timely completion of audit responses, supporting operations to ensure responses are appropriate, including ensuring appropriate corrective and preventative actions are implemented and liaising with the client to deliver responses with in the agreed timelines and respond to any resulting follow-up.

Leading quality issue investigations, including ensuring appropriate root cause analysis is performed, and adequate corrective and preventative actions are implemented.

Ensuring CAPAs are formally recorded and reported and actions are documented and followed until resolution.

Identify and track required effectiveness checks and ensure checks are completed within the required timelines.

Providing advice and support to the operation teams where needed to ensure CAPA are compliant with GCP and applicable regulatory requirements.

Supporting other Q&C teams with audits of ICON, including conducting audits of ICON, investigator sites and/or vendors, when deemed necessary.

Qualification

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External auditsCAPA managementRoot cause analysisClinical data evaluationDrug development knowledgeGCP Guidelines

Required

Knowledge/experience in hosting external audits and/or regulatory inspections.

Knowledge/experience in CAPA management, including performing effective root cause analysis.

Ability to review and evaluate clinical data/records.

Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.

Detailed understanding of drug development and clinical trial process.

Good problem resolution skills.

Good planning and organizational skills with the ability to multi-task and prioritize effectively.

Ability to work efficiently and independently under pressure.

Ability and willingness to travel on occasion to accommodate the client.

Preferred

Experience of GCP Guidelines and relevant regulations for the conduct of clinical trials would be beneficial.

Benefits

Various annual leave entitlements

A range of health insurance offerings to suit you and your family’s needs.

Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.

Life assurance

Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Company

ICON plc

Glassdoor

3.7

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life.

Founded in 1990