GMP Quality Professional

Posted 22 February by Envigo

At Envigo, we are working together to build a healthier and safer world, we exist to help our customers secure the potential of their research and develop products that enhance and enrich life.

Th e scope of this role is dependent on experience and covers the plan ning , conduct & report ing Quality Assurance activities to assure compliance with GMP, company policies & SOP’s. Contribute to continuous improvement.

This job contributes to organizational success by:

  • Carrying out the following Audits & Inspections activities:
    • Project plan and project set up verifications
    • Procedural inspections
    • Report or Certificate of Analysis audits/ analytical batch record reviews
    • Systems Audits
  • Interpreting, presenting & distributing own audit findings to the Project Manager & Management and follow up on corrective actions, discussing responses to observations
  • Maintain and up to date knowledge of software applications necessary to perform QA procedures
  • Being a QA signatory
  • Assist in reviewing the following documentation:
    • SOPs.
    • Reviewing deviation reports, OOS reports , change control and other GMP documents
    • Modifying QA SOPs for submission to the approval process

· At senior levels contribute or lead Quality event investigations

  • Maintaining an up to date knowledge of the requirements & expectations of G M P regulations as related to the role
  • Assisting in the delivery of the training programme for all QA staff
  • Contributing to the delivery of G M P training of study staff
  • Contribute to continuous improvement discussions within own department and across other areas.

Job Requirements:

  • Degree or equivalent and appropriate experience in a regulatory environment.Understanding of the techniques and procedures of process or specialised system. Knowledge and skills are normally acquired through broad training a
  • Reference: 34534692

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