Back to jobsQA review and approval of deviations, CAPAs, change controls, PM Plans, Work Orders
QA review and approval for master batch records (MBRs), SOPs, specifications, raw materials, executed batch records for all unit operations
Performing Area Clearance, Change over operations and OTF support for manufacturing operations
Independently providing forward processing decisions during manufacturing discrepancies
Lead and own disposition activities for the release of API, DS and DSI
SOP generation and ownership for Quality related functions
Ensure adherence to Quality systems for internal manufacturing facilities
Quality oversight of New Product Introductions / Product Re-introductions
Lead and drive site inspection readiness and provide QA support in partner audits and regulatory inspections
Serves as primary QA contact during Major / Critical manufacturing events
Lead complex cross-functional investigations
