Sr. Executive - QA - Alembic Pharmaceutical Ltd. - Panelav, Vadodara, Gujarat
(2020-09)
- Review and approve the Analytical Method Validation / Verification / Equivalency / Technology Transfer TDS, Protocol and Report.
- Coordinate with RA and QC team for the required document for Regulatory submission.
- Review and Client query compliance of analytical method transfer documents like Protocol, Report, Raw Data of API & Finish Product.
- Co-ordinate with respective departments for all document for Analytical method transfer of API as well as Finish Product.
- Review the our as well as vender document compliance for method Transfer like DMF, Dossier, STP & Specification.
- Review the Change control and Deviation.
- All take care of Review and compliance of analytical method validation, Raw material, IP, SFG and FG raw data.
- Online review and compliance of analytical raw data (Analytical Chromatography review with Audit trails)
- Online review and compliance the Audit trails of different instrument software's.
- Review and investigate the Incidence, Laboratory errors (Pre-Sample Investigation Report (PIR), Laboratory Investigation Report (LIR), OOS and OOT.
- Handle the query of Regulatory agencies and client.
- Performed the Excel sheet validation activity in Ixls Software.
- Handling the different documents software like DCS, Documentum, LIMS and QMS Software.
- Regulatory Markets: USFDA (US), EU (European Union), Brazil
Research Scientist - Analytical R&D - Centaur Pharmaceuticals Pvt. Ltd. - Hinjewadi, Pune, Maharashtra
(2015-09 - 2020-09)
- All take care of analytical method validation documentation activity like review the protocol, report, raw data, online review the raw data for e-signature, laboratory error, incidence and deviation related to validation activity.
- Coordinate with RA and QC team for the Required document for Regulatory submission.
- Review and Client query compliance of analytical method transfer documents like Protocol, Report, Raw Data and Client Query of API & Finish Product.
- Co-ordinate with respective departments for all document for Analytical method transfer of API as well as Finish Product.
- Review document compliance for method Transfer like DMF, Dossier, STP & Specification.
- Review and compliance of Analytical Method Validation / Verification / Equivalency / Technology Transfer of analytical methods protocol, report and data.
- Review and compliance of Analytical Method Development report and raw data.
- Review and compliance the COA of drug product and raw data.
- Review and compliance of Audit Trials of different instrument like HPLC, UPLC and UV.
- Review of Standard Test Procedure (STP) and Specifications.
- Handling the Quality system documents like Change control, Deviation, Incidence, Document correction.
- Review of departmental Standard Operating Procedures (SOPs) and impart the training.
- Review of calibration raw data, report and monitoring the calibration schedule.
- Involving in internal audits for compliance in safety and online documentation. Monitoring the laboratory for compliance of GLP.
- Daily review and compliance of Instrument log books (HPLC, UPLC, GC, dissolution, UV Spectrometer, balance, pH meter etc..), instrument calibration status, column usages log, Consumption and status of primary, reference and working standards, impurity standards.
- Document control and maintenance.
- Review the qualification documents of analytical instruments.
- Handling the USFDA, MHRA and different client's regulatory queries and response to compliance.
- Experience to face the audits like USFDA, MHRA, client, inter-department and internal audits.
- Prepare and review of employee on job training of schedule.
- Involve in document archival procedure and various format issuances.
- Review the Product Development Report (PDR) and raw data.
- Regulatory Markets: USFDA (US), EU (European Union), MHRA (UK)
Research Associate - Analytical R&D - Lupin Ltd. - 46A/47A, Nanda, Mulshi, Pune, Maharashtra
(2014-07 - 2015-08)
- Preparation of Analytical Method Validation protocols and reports of different test and different dosage form.
- Validation of Analytical methods of test like Dissolution, Assay, Related Substances, Moisture Content, Colour Identification test, Viscosity, IR spectroscopy of drug products of different dosage form.
- Preparation of Waiver for drug products.
- To work for Regulatory Quarry.
- Experience to Face the Internal audits.
- Regulatory Markets: USFDA (US), EU (European Union)
Research Associate - Analytical R&D - Centaur Pharmaceuticals Pvt. Ltd. - Hinjewadi, Pune, Maharashtra
(2012-02 - 2014-06)
- Preparation and review of Analytical Method Validation protocols and reports for assay, related substances, dissolution and residual solvents.
- Preparation of Cleaning Method validation and Method transfer Protocol and Report.
- Validation of Analytical methods of test like Moisture Content, Colour Identification test, Viscosity, IR spectroscopy, Dissolution, Assay, Related Substances of drug products.
- Technology Transfer of analytical method of drug product by HPLC, UPLC and UV.
- Calibration of Instruments like HPLC, UPLC, pH meter and Balance.
- Analysis of finished product of different dosage form for different tests like Dissolution profile, Assay, Related substances, Content and Blend uniformity.
- Method development for new drugs product by HPLC and UPLC (Oral Solid Dosage Form and Suspension).
- Regulatory Markets: USFDA (US), EU (European Union), MHRA (UK)
