Review of Analytical Method Transfer/Analytical Method Validation Protocols and Reports.
Review of Analytical documents related to Batch/Material Testing, Process Validation, Process Verification, Hold time study, Deblister study and Cleaning Validation.
Review of Out of Specification/ Out of Trend.
Review of Stability Reports and stability schedule.
Coordinate with QA manager for the release of Globalpharma products.
Daily monitoring of GLP compliance in QC lab including microbiology laboratory.
Review of QC Existing Instrument Calibration & Preventive Maintenance Reports.
Review of QC New Instruments Qualification documents, review of trends & reduced testing reports
Review of SOP, specification, standard testing method and Product Technical specifications.
Issuance, distribution and retrieval of documents (BMR,BPR,SOPs, specifications, protocols and other documents).
Preparation and review of QA SOPs.
Compliance of Validation reports.
Creation of Change control in caliber.
Preparation of APQR.
Daily monitoring of GLP compliance in QC Lab.
Coordinate with QA Manager for release of Globalpharma products.
To assist QA Manager in other activities.
