Sellersville, Pennsylvania30+ days ago
Release or reject API: Maintain decision making authority and maintenance of systems to release or reject API, intermediates, starting materials, raw materials, processing aids, packaging components, and labeling; Oversee system to ensure materials are produced and tested in a manner consistent with the applicable regulatory findings; Ensure that ancillary documentation including cleaning records, environmental monitoring records, calibration records, etc. are appropriately reviewed and approved by QA; Oversee system for preparing Certificates of Analysis, Certificates of Conformance, Summaries of Test Results, BSE/TSE Certification, and Approved Labelling, as required by client. Inspections and Audits: Assume lead role in regulatory inspections and client audits, prepare responses to audit findings, direct implementation of corrective and preventative actions (CAPAs); lead PPS-Sellersville’s internal audit program, schedule audits, prepare reports, direct implementation of CAPAs; lead PPS-Sellersville’s external audit program, schedule audits, prepare reports, monitor contractor/supplier implementation of CAPAs; participate in implementation of quality agreements with clients, contractors, and suppliers.