We are looking to recruit a QA Equipment & Validation specialist to provide QA oversight on all validation activities and to advise all Validation personnel on the GMP guidance and legislation to ensure BPL Elstree is compliant state.
Also to review, request additional information and approve all types of validation documentation
Key areas of responibility are :
To critically review and approve maintenance and validation documentation for the BPL Elstree on behalf of QA to ensure compliance with GXP requirements.
To critically review and approve process validation documentation on behalf of QA to ensure compliance with GMP requirements
To act as a QA reviewer and assist with deviations and root cause investigation.
To act as a QA stakeholder for controlled changes relating to key equipment or validation as required
To act as a QA representative as required at project meetings or working parties on the modification or replacement of key manufacturing equipment or Utilities.
To act as a trainer for QA on equipment and validation subjects
To review and authorise on behalf of QA all Engineering and Validation documentation
To keep up to date with current GEP / GMP guidance and legalisation to ensure site systems are compliant or aligned to best practice
To act as QA reviewer for media and validation batch records as required
To perform any other duties as required by the business and the QA Director
The person must have at least 5 years pharmaceutical GMP experience.
The person must be experienced with the validation of pharmaceutical equipment, utilities and processes within a Steriles facility
The person must be educated to degree level / or equivalent in a science or engineering subject.