Nirav Sheth Email & Phone Number

Gurugram, Haryana, India

• Responsible for review and release of specifications, ATP and related documents including API for US and Emerging Market• Responsible for query related activities related to analytical development and its implementation of learning in ongoing similar development / filing projects.• Responsible for conducting specification meeting for Oral project for all advanced and EM market.• Responsible for review / evaluation of analytical documents, Validation reports, Verification reports, justification reports, which are submitted to various agencies.• Support to resolve Technical issues related to Documentation, Specifications, Analytical Method Validation / Verification. • Responsible for outsourced DMF /CEP review for ongoing development projects for various markets.• Responsible for vendor updates/addition & its implementation for commercial APIs at mfg. sites to maintain business continuity required for various Emerging markets.• Responsible for implementation of elaborated method in ATP in place of current pharmacopeial methods for ease of understanding for QC analysts by including Central of Excellence and CAL related recommendations.• Support resolve technical issues related to documentation, specification, analytical method validation / verifications• Responsible for discussing technical issues related to ADD and CAL with sites.• Responsible for smooth functioning and co-ordination across document teams of sites for harmonization and simplification.• Technical support to site for CAPA evaluation and resolving it by providing analytical support during LCM for smooth functioning at Commercial site• Responsible for Pharmacopeias compliance theoretical gap assessment activities• Responsible for monograph sponsorship to various Pharmacopoeias agencies like USP.

Vadodara, Gujarat, India

Analytical Compliance Cell: Literature review and evaluation of polymorphic form of various API. To prepare the Method development Report / Polymorphic Report of Drug substance. To ensure the development and validation activity of XRD, for drug substance and drug product both, on the basis of literature review. To prepare protocol and report for the Validation activity. To perform the “Hygroscopicity Study” of Drug substance. To plan and execute XRD / DCS / TGA analysis and report the results.Mass Department: Responsible for the planning of Validation on LCMS /GCMS. Responsible for the Development / Validation of Nitrosamine impurities in various drug substance. Responsible for the planning of Metal screening Validation on ICPMS. Responsible for the planning and execution of Cut-off Validation on LCMS /GCMS. Screening the impurity by LCMS /GCMS.GLP Department: Responsible for the preparation of Calibration Master schedule / Maintenance schedule. Planning of calibration activity of all instrument as per schedule. To ensure the GLP activity by maintaining required Instrument log books / Laboratory Note Books. Maintaining and reviewing of Calibration data / Maintenance report. Responsible for the preparation of Instrument SOP, STP of Drug substance and its Intermediates on the basis of Method development Reports.Documentation Cell: Responsible for the preparation of Instrument SOP, STP of Drug substance and its Intermediates on the basis of Method development Reports. Responsible for the preparation of Protocols and report of LCMS /GCMS. Responsible for the preparation of Cut-off Protocols and reports of LCMS /GCMS. As and when required responsible for the preparation of Protocols and reports for various method. Responsible to review the data of various validation / cut-off validation. Comply the system by reviewing and closing the incident and Out of Variance.

Vadodara

 Successfully lead a team for NDDS, ANDA and Domestic product. Method development of ANDA, NDDS and Domestic product. Validation of ANDA, NDDS and domestic product on the basis of ICH guidelines. Monitored and reviewed method transfer protocols and reports for raw materials and finished products. Review of stability data for R&D and scale up data as per ICH guideline. Analysis and reporting of CDER query. Imparting training to staff for better work practices. Preparation of SOP’s for different equipment. Co-ordination with manufacturing location, CQA, ADL for the compliance of NCR, OOV. Review of Product development report Responsible for the Method Transfer at various plants.

Plan and conduct analytical activities associated with the development and testing of both generic and innovative drugs.Method transfer for raw materials and finished products.Validation of newly developed method of ANDA product including cleaning validation for the US market.Regularly reviews of projects/assignment of validation before submissionRespond to more complex queries from CDER through timely execution

JOB PROFILE- Develops and manages the operating and capital budgets for the division.- Preparation and reviewing the protocols and documents of validation. - Managing the method development for pharmaceuticals preparations. - Preparation, maintaining and characterization of Reference and Working Standards.- Conduct physical characterization of drugs.- Review and Documentation for Regulatory compliance.- Provide planning and management services for all phase of research projects.- Performed quality assurance role within the research and development function.- Analytical method development, optimization and method transfer with relevant protocols.- Validation of newly developed method of DMF product including cleaning validation for the US generic market.- Performed trend analysis of stability samples and determined the stability acceptance criteria.ACHIEVEMENTS:- Went twice to JAPAN as a representative of the company for the analysis of the product which helped the company to get the approval from JAPAN Government

Overall in charge of shift.Performed in-process and finished product testing as per the compendial and in-house methods.Performed raw material testing of products as per the specified method.

Master Of Science, Analytical Chemistry

Bachelor Of Science, Chemistry

Diploma In Marketing Management