Celerion

Clinical Research

QualityAssuranceAuditor

£30–42k ~AI est. Belfast, Northern Ireland, United Kingdom FULL TIME Remote Friendly
Market Sentiment
HIGH DEMAND

Neural analysis suggests this role is
optimal for Mid+ candidates.

The Brief

“Quality Assurance Auditor at Celerion. Skills: Quality Assurance, Auditing, GCP environment. Assess study compliance. Assure project compliance”

Industry & Context.

Clinical Research
Problems you'll solve

Root cause analysis

Eligibility Requirements

Ability to travel

What They're Looking For.

Must Have

2-5 years quality/laboratory/clinical experience, Proficiency in using electronic data and computerized systems

What You'll Do.

Assess study compliance

Assure project compliance

Assure process compliance

Audit project reports

Audit process reports

Report audit findings

Determine acceptability of responses

Interact with clients

Discuss QA observations

Maintain working relationships

Participate in improvement initiatives

Lead improvement initiatives

Detect quality issues

Detect need for CAPAs

Assist with client audits

Assist with regulatory inspections

Host regulatory inspections

Participate in System Audits

Participate in Vendor Audits

Conduct System Audits

Conduct Vendor Audits

Follow-up for System Audits

Follow-up for Vendor Audits

How You'll Work.

Team & Collaboration

Internal and external clients; Across departments

Communication Scope

Oral communication; Written communication

Full Job Description

## Description     Celerion is committed to swift, exceptional clinical research through translational medicine.  Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.  Celerion offers one of the most experienced clinical pharmacology research networks in the industry. Are you looking for an opportunity to be involved in creating life-saving treatments? If so, we can't wait to meet you!   Celerion, a leading global contract research organization, seeks a Quality Assurance Auditor to support our rapidly growing Data Management and Biometrics department. The successful candidate will have Quality Assurance expertise within a GCP environment. This role will be located at our Belfast, Northern Ireland facility.   Role: The role of the Quality Assurance Auditor is to assess and assure study, project and process compliance with protocols, Controlled documents, and applicable regulations and guidelines through audits. ## Responsibilities Carry out auditing of study, project, and process reports, records and data; report audit findings to operations via QA audit reports; and determine acceptability of the responses and verify the corrections (includes but not limited to Clinical Study Report audits, Protocol audits and Electronic Database Capture (EDC) audits). Interact with internal and external clients to discuss QA observations and study-related issues; and maintain effective and professional working relationships within and across departments in relation to study projects. Participate and lead in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes. Detect quality issues and the need for CAPAs and evaluate deviations Assist with the preparation for and hosting of client audits and/or regulatory inspections. Participate in the preparation, conduct and follow-up for System Audits and Vendor Audits ## Qualifications Ba

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