Paras B Majmudar

Experience

• 

  Meyer vitabiotics

  May 2009 - Sept 2009

  Medical representative

  marketing & sales

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  J.b.chemicals & pharmaceuticals limited

  Oct 2011 - Dec 2013

  Qc executive/lims incharge

  -in-charge of laboratory information management system-harmonization of systems-support for regulatory audits-preparation of stps & sops in accordance with pharmacopoeias-checking glps-capa- implementation of quality system-cleaning validations-cgmp compliance-handling of instruments-training-sap-maintaining approved vendors list

• 

  Cipla

  Jan 2014 - Sept 2015

  Corporate documentation

  preparation on documents and providing annotations on document software (cipdox)preparation of specifications, sops, general analytical methods for all stages of manufacturing with approval from associated departments.preparation of annual product quality review, history, method of analysis.compilation of data for dossier submission and dmf filing, impact assessment.obtaining data from purchase, adl,regulatory departmentcapato meet time frame for submission by providing required documents, gap analysis between dossier and existing related documents in response to regulatory requirements. review of pharmacopoeias and literature. literature search and review.communications with other departments and point of contacts and complete the assigned project via teleconference and meetings show less

• 

  Abbott

  Sept 2015 - now

  1) end to end quality monitoring of third party manufacturing (tpm) sites (west zone) of abbott w.r.t. cgmp & regulatory requirements.2) review, implementation & managing the quality management system at tpm sites w.r.t. abbott products.3) review and approve changes in suppliers/vendors involved in abbott’s products.4) due diligence activities for new tpms/vendors.5) assuring smooth functioning of s&op initiatives, capacity analysis, inventory management,6) implementation & review of continues improvement activities.7) preparation of risk assessments of tpms.8) review, preparation & maintenance of quality technical agreements.9) supporting ms&t team in product improvement projects.10) spoc for all supporting activities at tpm.11) review of stability data of tpm sites for abbott products.12) providing trainings at tpms as per the training schedule.13) change control management, review & approval of exception reports, deviations, & capa in trackwise.14) logging, review, investigation & closure of market complaints via trackwise software within the defined timeliness.15) spoc for reviewing, compliance tracking & implementation of periodic compendial changes (ip/usp/bp/ph. eur/jp) for abbott.16) responding to customer complaints and queries.17) handling product recalls.18) supporting in audit capa verification and preparation of risk assessment of tpm sites.19) artwork review & approval as per drugs & cosmetics act 1940 & abbott global guidelines using harmony software.20) export barcodes label review & approval (track & trace labels) as per director general of foreign trade (dgft) requirements.21) performed validation of track & trace software (verif-i universal parent child & verif-i collation software from acg inspection) in accordance with dgft guidelines for abbott’s hubs and cfa.22) warehouse & cfa visits for reviewing the good distribution practices.23) representing tpm qa on different global projects. show less 1) quality monitoring of third party manufacturing (tpm) sites (west zone) of abbott w.r.t. cgmp requirements.2) review the quality management system at tpm sites.3) review of stability data of tpm sites for abbott products.4) quality overview & implementation of gdp & quality management of cfa's & warehouses. 5) change control management (trackwise), review & approval of exception reports, deviations, & capa.6) logging, review, investigation & closure of market complaints via trackwise software.7) responding to customer complaints and queries.8) handling product recalls.9) supporting in audit capa verification and preparation of risk assessment of tpm sites.10) artwork review & approval as per drugs & cosmetics act 1940 & abbott global guidelines using harmony software.11) export barcodes label review & approval (track & trace labels) as per director general of foreign trade (dgft) requirements.12) performed validation of track & trace software (verif-i universal parent child & verif-i collation software from acg inspection) in accordance with dgft guidelines for abbott’s hubs and cfa.13) preparation, review & approval of sops in solid software.14) preparation and archival of documents for various ongoing projects.15) preparing and maintaining trackers for various ongoing projects.16) preparation of weekly, monthly reports for senior management review.17) preparation of presentations for senior management review. show less

  • Assistant Quality Assurance Manager

    May 2018 - now

  • Quality Assurance Executive

    Sept 2015 - Apr 2018