Title: Officer- QA Doc Cell and Sampling
Date: Sep 12, 2022
Location: Dewas API - Quality Assurance
Company: Sun Pharmaceutical Industries Ltd
To perform Management of document cell.
Document retrieval and issuance with EDAMS software
Storage and destruction of document as per document handling SOP
To perform finished product sampling of Sterile API as per SOP.
Environmental monitoring data punching and trend preparation and its evaluation.
Preparation of bioburden trend and its evaluation.
In process, Environment Monitoring, water, and finished product sampling as per Printouts of automated systems like DHS, Autoclave, IT exacta machine, Lyophilizer e.Batch production/batch cleaning record review and filling of batch review checklist.
Review of BMS and FMS trends.
Finished product labeling and relabeling, secondary packing operation and related documents.
Review and archival of documents generated by IPQA and QA as per SOP.
To perform cross contamination sampling of Sterile API as per SOP.
Qualification: B Pharma, BSc, MSc.
Experienece: 2 to 5 Years with working experinec in regulatory approved Sterile API manufacturing plant.
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