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:
- 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.