• Responsible for Authoring and review the change control for compilation of a Annual Report for US Market (Merck Project).• Handling the queries received form CMC Scientist and change originator on change control and Annual report.• Responsible for Quality control check and maintaining timeline for Annual Report submission to USFDA.• Working on tool such as- Veeva Vault (RADAR-for LCM attribute and Module 3 doc’s), Service Request form (for GCM request), GCM trackwise (Documents for change control which need to be author), Team space(sharing any doc’s), Cognos (for RRR & Validated query report, RCAM has been updated now with REDS for AR compilation, Exostar for E-sign, MIDAS(for BCR Report, COA and other attachment which where mention in BCR Report).

•• Preparation of Dossiers in CTD modules for SSA countries (Sudan, Mauritius, Mozambique, Madagascar, Uganda, Zimbabwe, Kenya, Zambia, Tanzania, Ethiopia).Preparation of Renewal dossiers submitted for Sudan, Madagascar & Mozambique.• Variation filling to Madagascar, Mauritius, Mozambique, Sudan, Kenya, Ethiopia, Zambia & Tanzania.• Ensured that regulatory submissions are done as per country's regulatory guidelines & as scheduled.• Tender:Coordination with unit for arrangements of necessary data from unit for submission of Tender application for Mauritius, Mozambique, Kenya, Zambia, Tanzania & Uganda.• • Deficiency Response- Prepared workplan as per deficiency received.- Arranged CFT with cross functional teams to discuss on the queries received from MOH.- Compliance of final deficiency response.- Arranged for the necessary documents and responded to the queries to Ministry in stipulated time. Solved queries received from Customer on regular basis.• Support to cross functional teams.- Ongoing support to BD, Manufacturing units by providing adequate regulatory information for Mauritius, Madagascar, Sudan, Mozambique, Uganda, Zimbabwe, Ethiopia, Tanzania. - Co-ordination with LCM for workability and initiation of renewal dossiers & variation packages for Madagascar, Sudan, Mozambique. - Effective co-ordination with internal stake holders to obtain information required for regulatory submissions & deficiency responses.- Remittance Activities are done for payment of new registration, variation and renewal fees to MOH & customer for Mozambique, Madagascar, Uganda & Zimbabwe.- Collated information mfg lic,FPS,& GMP required for company registration on website of Quntrol Laboratories as a pre-requisite for pre-shipment analysis of Mozambique consignment.- Evaluate the change control & give comments as per guideline for various countries, gap analysis done for FPS, New FG code has been created.

1)Preparation of dossiers for ROW countries in CTD & ACTD format.2) Application for product Permission & COPP at local FDA.3) Application For NOC at CDSCO.4)Preparation of Technical files for medical Devices.5)Checking of artwork as per regulatory requirement for both domestic & Export(Commerical purpose and registration purpose).6) Coordinate with various contract mfg company for docs needed for dossiers compilation.7) Prepare Cria report for Nigeria.8) Filling COC (Certificate of Conformity for Kenya. 9)Preparaing MSDS of finished product and working standard for transportation.10) Prepare medical device dossiers for Guyana, Kenya & Uganda.

1) Preparation of dossiers for ROW countries in CTD & ACTD format (for Vietnam, Philippines, Cambodia, kenya, Yemen).2) Artwork checking as per regulatory requirement for both domestic & Export (Commerical Batches) and registration purpose.3) Outsourcing of finished products analysis to NABL accredited labs country or party requirement.4) coordinate with plant for documents needed for dossiers compilation.5)Coordinate with plant for samples and WS for registration purpose for regulatory dept.

1)Production department : Compression ,Coating2)Daily output entry in SAP and DPR entry.3)Handling 50 workers team.4)Dispensing of raw material from store dept as per Batch planning.5)Filling log book ,temp & Humidity.6)Filling BMR.7)Inspection of punches.8)checking IPA & MDC