Asha Patel Email & Phone Number

About 6 years of experience in Pharmaceutical industry in Quality Assurance.Review of executed Batch Manufacturing Records, Batch Packaging Records, Master Formula Record. Preparation of Annual Product Quality Review.Deviation management, Root cause analysis, Investigation and CAPA. Initiation, Review and approval of change control. In-depth review of Technical documents like Validation Protocol and Reports, Stability Testing Protocols, Trend cards, Dissolution Development reports, Calibration Data of Instruments like HPLC, UV- Spectrophotometer. Review of raw data and calculation of method development trials and method validation. Review of Certificate of Compliance (C of A) and checking whether the results meet the specification or not. Effective Implementation of Quality Management system within the Organization by performing Internal Audits. Preparation of Audit Agenda and Audit reports.Issuance of OOS, OOT and Reviewing Investigation reports of the same. Review the data in compliance with cGMP. . I also have hands-on experience in handling HPLC, UV Spectrophotometer, ATIR.Issuance and checking Laboratory Notebooks, Instrument Logbooks, Column usage records, Reconciliation records

Listed skills include Laboratory, Microbiology, Microsoft Office, Life Sciences, and 14 others.