Job Description
4 filing lines client is getting ready for the first submission and there is a lot of support needed to support quality of the PV process as well as transfer activities. Quality review and approval on validation lifecycle, procedures and maint. the engineer will provide compliance input into the system specs, procurement and commissioning activities as well as ongoing validation and change control. Provide overall direction during activities and function as the expert on quality validation strategy and procedure. Ensure GMP and GDP compliance is maintained throughout the validation lifecycle. Perform data analysis and interpert progress, results of work. Document evaluations, review and approval for URS, FRS, FS, DQ, I / O / PQ, PPQ, validation batch records, change requests, risk assessments and all validation reports. Establish functional processes and SOP’s ERES review and approval
Required Skills/ Experience
QA, Validation experience cGMP, Pharma knowledge of validation documentation along with facilities, utilities, manufacturing and lab processes including those with CSV
Other
Vax required drug and background check
NC: Quality Engineer, Validation (3) spots (232705)
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