Nirav Rana
- Role
- Qa Inspector Iii at Amneal Pharmaceuticals
- Location
- Passaic, NJ, US
- LinkedIn followers
- 500 followers
About Nirav Rana
As a QA Inspector with over 5 years experience in Pharmaceuticals. I specialize in…
Experience
Qa Inspector Iii
Dec 2021 — Present
Performe inspection, sampling/testing on all incoming raw materials, packaging components according to cGMP Standards.#Monitor and release of Purified Water System.#Performs rinse and swab sampling for microbial cleaning verification.#Prepare controlled/uncontrolled/packaged finished product samples for QC lab and QA retains.#Perform and approve room, equipment, and packaging line checked prior to each stage of manufacturing.#Preparation of specifications and standard test procedures of QA in-process, finished products AQL and packaging materials AQL.#Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor-related functions).#Review of manufacturing/packaging batch records in terms of completeness of signatures, entries, and actual reconcilaiton / yields prior to initiation of the next processing step Verification of functionality of all the equipment and associated controls during the batch run.#Preparation and review of Annual Product Quality Review Reports.#Preparation of SOP\'s and implementation of new procedures after approval and training to Concerned.#Review of process study protocols, cleaning validation protocols, SOP\'s, Change controls, and Master Batch Records.#Collection of packaged product samples for annual, submission, process validation and scaleup stability.#Non-Conformance/Investigation, Corrective action-Preventive action(CAPA), and change control(CC) are initiated, tracked, reviewed and closed by the engagement with local and global QA units.#Compliance of warehouse area in terms of isolation of quarantine, released, in-process, finished product, packaged product, returned goods and rejected areas.#Maintenance of retention sample room and monitoring of temperature and humidity, replacement for chart records as per schedule, review of log and disposition of samples.
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