Experience

Eurofins Alphora, Alphora Research Inc

• Quality Assurance Technician

  • Oct 2018 - Present

  - Responsible for online review of running batches in production. - Responsible for implementation of GMP & GDP guidelines in quality and production areas. - Perform complete review of executed batch records and QC data for accuracy, completeness and GMP compliance. - Performing inspection rounds in QC and production, reporting any findings that are not GMP and suggesting solutions on how to incorporate those guidelines. - Perform equipment and plant clearance before commencement of a new batch. - Assist and take part in complaint investigations in case of customer and audit issues to determine root causes and corrective actions. - Perform review of equipment and instrumentation logbooks. - Monthly review of calibration & preventive maintenance schedules. - To ensure release of materials and batches in ERP. - To initiate, issue & review amendments, deviations.



Torrent Pharmaceuticals Ltd

• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA/QC Executive

  • Aug 2012 - May 2018

  - Job responsibilities included retrieval of batch records and logbooks in timely manner. - Review of quality analytical data and Production Batch Records (PBRs). - Ensure compliance of SOP at ground floor production & quality areas. - Preparation of audit responses & ensuring compliance as per committed timelines. - Issuance of logbooks, amendments, analytical raw datasheets and sampling forms. - Responsible for sampling and testing of all types of packaging materials. - Handling, usage and calibration of various instruments used in PMQC Lab i.e. Scuff Tester, Pin Hole Tester, Box Compression Strength Tester, Puncture Resistance Tester, Bursting Strength Tester, IR Spectrophotometer and Weighing Balance. - Wet lab testing of API samples and qualifying them as reference standards. - Experienced in using SAP and MS-Office.