Devendra Patel Email & Phone Number

Sacramento, Ca, Us

Ahmedabad, Gujarat, India

● Follow up with cross functional teams, collection and final Review of documents for regulatory submission.● To support compilation of pdf documents, its assembling and quality review in electronic (eCTD) format.● Compilation & review of Original ANDA submission of dosages form (Parenteral)● Keep up-to-date with changes in regulatory guidelines and sharing with colleagues.● Compilation and review of deficiency responses for Original ANDAs.● Post approval supplements/Variations filing, CBE0, CBE30, PAS.● Technical Review of all the CMC documents. ● Module 1, Module 2, Module 3 Authoring for ANDA, PFC and supplements/Variations submission.● Product life cycle management. ● Regulatory Inspection readiness verification.

Ahmedabad, Gujarat, India

Line clearance activity for different stages of batch manufacturing and packing.● Review CIP-SIP reports and audit trails related to it.● Review leaktest and VHP cycle reports for Isolater.● Participate in aseptic process simulation study.● Performed IQ, OQ of autoclave. (Make- PharmaLab)● Performed qualification of compressed air and nitrogen gas used.● Performed IQ, OQ of Vial washing machine, Depyrogenation tunnel, Vial filling and capping Machine. (Make- Steriline)● Participated in PQ study of terminal sterilizer. (Make- Shinva) ● Participated in PQ study of Manufacturing Skid. (Make- Adam)● Performed line clearance activity for Material issuance, Dispensing, Manufacturing, Filling, Autoclave, Terminal Sterilization and Packaging Activity.● In process sampling and testing for pH, Conductivity, TOC, Dissolved oxygen samples.● Review of BMR, BPR online with batch reports and audit trails.● Handling of Deviation, Change Control and CAPA.

Ahmedabad, Gujarat, India

Performed Line clearance activity for Dispensing, Manufacturing, vial washing and depyrogenation, Filling, Packaging and Dispatch.● Sampling for different stages of manufacturing and filling for in-process and finished goods testing.● Sampling for stability sample and retain sample.● Sampling for different stages of process validation and cleaning validation batches.● Verification of autoclave and filter integrity reports.● Online and final Batch manufacturing and Batch packaging record review.● Issuance of BMR, BPR, Standard formats and other QA documentation related work.● Preparation of SOP and handling its related change control.● IQ, OQ activities of TRACK N TRACE system in packaging.● Review of Audit trails for 21 CFR compliance systems and equipments.● Handling of Change control, Deviation and participation in investigation of root cause.● Handling of CAPA and its effectiveness.● Conduct Training for SOP, Validation protocols and other study protocols.● Conducting oversight observations.● Participation, monitoring and Review of Documents for Media fill study.● Knowledge related to Documentum, Track Wise and Track N Trace software.

Ahmedabad, Gujarat, India

● Line clearance for batch charging, Line clearance for sterilization.● Random checking of in process test at filling stage.● BMR/BPR Checking and Release.● Raw Material Dispensing Checking.● In process round in packing & Production Area verification of on line BMR, BPR. ● Sampling of in-process and finished product, stability and retain sample. ● Knowledge related to Change control, Deviation, CAPA. ● Knowledge related to QMS ACTIVITIES.● Handled change control, Deviation and CAPA.

Ahmedabad, Gujarat, India

Raw materials sampling, Analytical testing, result reporting.WFI, PW and pure steam sampling and testing. TOC analyzer installation IQ, OQ, PQ.Karlfischer titration, Brookfield viscometer, Potentiometric Titration.IPQA shop floor activity during production.

M.Pharm, Quality Assuarance, 64%

Bachelor Of Pharmacy - Bpharm, Pharmaceutical Sciences, 69%