Quality Assurance professional with a broad range of experience in non-sterile, sterile and biologic products. Experience base includes: oversight and approval of investigations, batch release, change control (process, equipment & automation), annual product reviews, customer complaints, conducting audits, hosting regulatory inspections, authoring and approval of SOP's, and executing risk based ...
|Title||Director EQA Large Molecule Drug Product|
|Skills||GMP, Quality Assurance, Validation, CAPA, 21 CFR Part 11, Computer System Validation, Pharmaceutical Industry, GxP, SOP, Project Management, Change Control, GAMP, Regulatory Requirements, FDA, Quality System, People Development, Equipment Qualification, Auditing, Batch Records, Batch Release, Electrical Controls, Process Automation, Software Quality Assurance,|
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