Rupali Thorat Email & Phone Number

Mumbai, Maharashtra, India

- Monitoring quality system compliance at Regional level and monitoring it for 11 affiliates and 2 sites.- Ensuring raising of Exception reports/ Quality documents for identified Gaps- Review of significant events/ recalls/ product investigations - Business Administrator for Darius & ISOtrain- Performing Pareto analysis and elevation of concerns related to Complaint & ER- Automation of quality systems from manual to electronic- Working closely on Site Quality Culture for site improvement- Leading implementation of Division lead initiatives at Regional/ Site/ affiliate level - Ensuing Preparation, Review, Approval, Periodic revision of documents (SOPs, Policies, QTA, Product Technical Documents, RCP, Job Descriptions etc.) along with impact assessment of Governing documents - Ensuring Continuous improvement at Region/ Sites/ affiliates

Mumbai, Maharashtra, India

Expertise in electronic learning management systems, SAP S4 HANA (SOP Module), certified Trainer, presentation skills, TWD (Quality Management System), Management skills

Mumbai, Maharashtra, India

Mumbai, Maharashtra, India

Pawai, Mumbai

- Handled of PQR compilation project for Teva- Europe : Responsibilities: I. Request PQR from 3rd party manufacturer of Teva Affiliates i.e. U.K., Spain, Portugal, Belgium, Switzerland, Netherland and Teva Pharma Europe (TPE). II. Collect mandatory product data from 3rd party manufacturer as well as from software Global Insight (GIBI) and MHRA's site i.e. RAMA portal. III. Collection of mandatory data from Regulatory affairs (Regulatory variations, Technical agreement, Post marketing commitments and marketing authorization) of Teva Europe. IV. Scheduling internal review for PQR of 3rd party manufacturer and all collected data from 3rd party manufacturer i.e. critical test, stability data and trends, deviations, change controls, out of specification results, out of trend results, complaints and also review of regulatory variations and complaints reported to Teva affiliates. V. After completion of internal review of PQR, review remarks are communicated to 3rd party manufacturer and PQR summary is finalized after receipt of response from manufacturer on review remarks. VI. Sending final copy of PQR summary to Qualified Person (Q.P.) in Tevapharm Europe for signing. - Handling APR Data Retrieval and APR compilation Project for Teva-CanadaResponsibilities: I. Coordinating with all departments for collecting production, analytical and customer data associated with Pharmaceutical product batches. II. Providing summaries of results and generating conclusions and recommendation reflecting data in the Annual Product review (APR). III. Organizing statistical data in appropriate tabular form and plotting graphs based on this data to generate proper conclusions. IV. APR data retrieval and compilation for all Teva-CA manufactured and 3rd party purchased finished goods and bulk products from software - Knowledge tree, Oracle, Track wise and LIMS databases.

Navi Mumbai, Maharashtra, India

- Quality System Documentation:1)Out of specification (OOS) and Out of trend (OOT):- Review of manufacturing process, physical parameters during manufacturing, raw and packing material used during manufacturing and packing, change control deviation and validation reference for respective product and batch to which Out of specification (OOS) and Out of trend (OOT) observed. 2) Annual Product Quality Review Report:- Compilation and preparation of Annual Product Quality Review Report. - Rolling Trends: - Preparation of Quarterly rolling trends for each product and finally compiled in Annual Product Quality Review Report. 3)Handling of Rejection: - Done investigation and confirm rejection after receiving intimation form respective department and intimate to purchase, collect suitable CAPA from supplier.4) CAPA: - Tracking of CAPA for packing material and raw material rejection. 5) Vendor Report Review: - Review and recording of vendor reports of regulatory and non- regulatory products.- ARTG Certificate and Technical Agreement: - Review and recording of Australian Register of Therapeutic Goods (ARTG) certificate and technical agreements.

Patalganga

I) Preparation Of Batch Release certificate: Prepare of Batch Release certificate and submit it to Product Registration Cell or Client. II) Batch Release and respective document review: Review of documents: - Review Master Batch manufacturing records and Master batch Packing records and Batch manufacturing record and Batch Packing Record. Issuance of Documents: - Issue Batch manufacturing record and Batch Packing Record. Log Books Review: - Review of entries done in manufacturing, packing, store Quality control department log books.- Dispatch of Drug/ Batch: - Submission and review of Batch Manufacturing Record, Batch Packing Record, Analytical Test Report, Technical Information Sheet and Product Release Request form dispatch the batch/ Drug.

Pg Diploma In Clinical Research, Pg Diploma In Clinical Research

Bachelor Of Pharmacy (B.Pharm.), B.Pharmacy

Activities and Societies: worked in Cultural group and worked as magazine secretory of college. B.Pharmacy