Professional experience in pharmaceutical manufacturing operations, in processes, final
inspections and knowledge of laboratory procedures in a clean room environment.
• Participates in the operation of filling, labeling & packaging equipment of varying complexity and in accordance with PMR, applicable SOPs, and ISO and cGMPs requirements to produce finished intermediates and final kits.
• Execute aseptic gowning and perform all filling tasks in the aseptic environment.
• Cleans work areas and decontaminates work surfaces in accordance with defined procedures, and performs duties in accordance with SOPs, QSRs, and all safety regulatory requirements.
• Perform environmental monitoring activities in the Filling Suites.
• Complete all necessary production documentation Production Manufacturing Records, logbooks, forms and other GMP documents.
• Accomplish SAP transactions to ensure that all components meet requirements pertaining to lot numbers, expiration dates, intermediates, reconciliation, good issues, good receipts and transfers of materials from different locations to
maintain accuracy for process orders and SLocs.
• Fulfill quality checks (Fill Check, Torque check, Vision System Check, Label Alignment Check etc.).
• Inspects products for defects and conformance to quality standards and applicable SOPs as well as applicable ISO and cGMP requirements.
• Performs warehousing activities according to defined procedures, which may
include picking, issuing, returns, internal distribution of goods, receiving, shipping, etc.
• Knowledge and perform EBR operations
•Performed tube/frame assembly, filling, labeling and pouching operations consistent with quality standards.
•Performed in-process quality checks for specific quality attributes (fill check,seal heights and label alignment check) and defects.
• Cleaned work area and decontaminates work surfaces in accordance with defined procedures and performs duties in accordance with all safety
requirements.
• Monitored laboratory supply inventory, replenishes lab supplies as needed.
• Performs general/routine laboratory maintenance/upkeep.
• Performed material handling activities according to defined procedures, which includes picking, issuing, stock transfer and receipt transactions.