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Quality Assurance

Last updated: 12:57 19/03/2012

Manager, Quality Assurance

Reference number: 1965 Apply for this job Apply for this job »
Type: Permanent, full time Location: Office based, Norfolk

Job Description

The Role:

  Supporting the Manager, Quality and Process Improvement, in

development of the Quality System to meet regulatory, sponsor and

business requirements

 Management of the company internal audit programme

 Managing the supplier and sub-contractor approval programme

 Collation, reporting and monitoring of compliance with internal

procedures and regulatory requirements

 Hosting and managing sponsor audits and co-ordination of responses

and follow-up

 Develop staff training programmes in order to ensure regulatory

compliance

 Involvement in regulatory inspections as required; key role in planning

and follow-up of GCP inspections

 Development of CAPA (corrective action preventive action) plans to address quality issues and non compliances

Experience/Qualifications required

Experience:

  Experience and knowledge of Good Clinical Practice

 Experience of developing and improving quality systems

 Supervisory or management experience

 Experience of planning and conducting internal audits and audits of

suppliers and sub-contractors

 Experience and knowledge of equipment and computer systems

validation requirements to comply with the principles of Good Clinical

Practice