SUMMARY:
This position is responsible inspection for in-process quality of the product at manufacturing, bulk/finished product packaging.
EDUCATIONAL QUALIFICATION:
Four year college degree or master degree; and/or two to three years related experience and/or training; or equivalent combination of education and experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
-
Ensures compliance with cGMP, Company SOPs and FDA requirements during all phase of operations.
-
Perform room, equipment, and manufacturing/packaging line checks (where applicable) prior to each stage of manufacturing and packaging following detailed written procedures. Conduct in-process checks as per manufacturing and packaging batch record instructions. Prepare bulk/finished product samples for QC lab and QA retains, following detailed documentation procedures. Ensure all logbooks are logbooks are completed and reviewed at manufacturing and packaging area.
-
Audits daily activities during manufacturing, chemical dispensing in pharmacy and packing area.
-
Performs swab analysis on specific equipment to ensure cleanliness.
-
Performs label verification prior to start packing of finished bulk product and cleaning verification prior to use of packing area.
-
Perform sampling for controlled sample, microbiology, validation and stability as required based on respective batch manufacturing record, batch packaging record and packaged product packaging specification.
-
Labeling component receipt, visual examination & preliminary inspection. Preparation of labeling components inspection reports; Issuance of labeling components according to packaging order and regular monitoring and auditing of label room.
-
Review of batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step
-
Verification of functionality of all the equipment and associated controls during the batch run.
-
Utilize various software applications using Microsoft Office, SySpro, Rite-Scan, QR Code, etc.
-
Create and maintain database specifications where appropriate for packaged product materials. Cleaning verification of equipment prior to use of manufacturing/packaging of product.
-
Compliance of Warehouse area in terms of Isolation of Quarantine, Released, In-Process, Finished Product, Packaged Product, Returned Goods, and Rejected areas.
-
Performs other duties as assigned.