GCP Compliance Manager in UK, East Anglia, Cambridgeshire

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Job Details

 ¦ 2621697

NOTE : This job has expired and applications are no longer being taken for it.


GCP Compliance Manager

Description : 
Responsibilities:


- Support, plan, conduct and report routine / directed compliance audits


- Report compliance concerns to Global Clinical Quality Assurance Management


- Participate in Global Clinical Quality Assurance projects


- Respond and recommend solutions to compliance concerns


- Maintain knowledge of current regulatory / GCP requirements


- Support Regulatory inspections as directed by Senior Global Clinical Quality Assurance Management


- Facilitate and support Regulatory Agency inspections


- Author and/or contribute to Global Clinical Quality Assurance SOPs, standard audit checklists and templates


- Provide coaching / mentoring to staff by the development of educational programs


- Represent Global Clinical Quality Assurance at assigned area meetings to deliver compliance advice


- Provide GCP and compliance advice


- Participate in quality improvement initiatives throughout Research & Development


- Investigate suspected scientific misconduct


- Provide quality metrics to program teams


Qualifications & Experience:


- Bachelor's degree in appropriate discipline or equivalent


- Knowledge and experience of the pharmaceutical industry


- Knowledge of the theory and practice of Good Clinical Practice (GCP) and/or of Auditing in any discipline


- Knowledge and application of GCP and relevant regulatory requirements


- Knowledge of basic auditing principles


- Basic understanding of multiple domains of the Certified Information Systems Auditor or Certified


- Information Systems Security Professional or equivalent (EPQA)


- Second language


1st IT People Limited is acting as an Employment Agency and/or Employment Business
Role : GCP Compliance ManagerThis job has now expired
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Type : Permanent
Location : United Kingdom, East Anglia, Cambridgeshire
Salary : £42000 - £47000 per annum + Car + Benefit
Main Industry : Manufacturing
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GCP Compliance Manager in UK, East Anglia, Cambridgeshire

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