Principal QA Auditor (GCP) job in Norfolk, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Good Clinical Practice (GCP)

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

This is an exciting opportunity to join a CRO team reporting to the QA Manager, you will provide day-to-day support to the quality assurance function. You will be responsible for assisting in the management of the Quality Assurance program and will work with other departments to assure regulatory compliance and consistency with the policies and procedures.

Job Responsibilities

Set up the annual quality audit programme
Ensure the quality audit programme is followed and kept up to date
Conduct reporting and follow-up of quality system, computer system validation and service provider audits
Ensure audit results are formally recorded and reported and that corrective/preventative actions are documented
Maintain the approved service provider list
Oversee production of the monthly QA report to management using QA metrics and escalate any issues for concern to the Head of QA
Production of the annual trend analysis using QA metrics
Participate in Client audits and regulatory Inspections (preparation, hosting, responses and follow up of corrective action plans)
Assist in the management, training and mentorship of our team of QA auditors and provide guidance on internal and external audits

Skills and Requirements

GCP and CSV QA experience
Experience with assisting and managing QA audits and inspections as well as interfacing with regulatory agencies
Experience in the management of documents (Policies, SOPs etc.)
Expert knowledge of GCP and applicable regulations
Demonstrates leadership ability, communication, and facilitation skills
Be able to work on own initiative and able to function independently or as part of a team

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.

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