Provide quality, technical support and oversight during manufacturing activities.
Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark.
Open deviations as appropriate based upon Spark Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed prior to material/lot release.
Review and evaluate QC testing records and any associated OOS investigations.
Review, write, revise, and approve SOP's, technical documents, and reports.