Summary
Overview
Work History
Education
Skills
Accomplishments
Additional Information
Certification
Online Certifications
Total Years of Experience
Timeline
Generic

Dipika Manna Sarkar

Deputy Manager - Global CAPA
Pune

Summary

Industrious and enterprising QA professional with impeccable record of contributions in software simplification, process management, audit and compliance at global level.

Seeking challenging assignments and projects in product-based as well as service-based organizations.


Overview

13
13
years of professional experience
4
4
years of post-secondary education
3
3
Certifications
1
1
Language

Work History

Deputy Manager - Global CAPA

Cipla Limited
06.2015 - Current
  • Effective evaluation and implementation of 37 Global CAPA's across 40 Units globally.
  • Key contributor for automation activities globally leading to savings of 520 man hours annually.
  • Preparing dashboards in order to gain insights into areas of improvement and ongoing status of CAPA's.
  • Improved user productivity and efficiency through system training and support on key topics of Data Quality.
  • Improved system performance by eliminating operational gaps and bridging gaps identified based on 10-15 483's and Warning Letters issued to other competitors leading to better customer satisfaction.
  • Documented diagnostic results and supported root cause analysis and troubleshooting. Implemented system correction related CAPA leading to reduction on repetitive complaints by 75%.
  • Performing routine visits in Units for verification of implemented Global CAPAs and for ensuring all time Audit readiness. Imparting training to respective units on shortcomings identified from review of Unit CAPAs.
  • Review of compliance reports of External / Regulatory Audits and support site in implementation of Extended CAPAs derived from External / Regulatory Audits at other Sites
  • Responsible for reviewing Corporate and Site / Unit SOPs and providing comments as required as part of Automation / Simplification.
  • Reviewing of Laboratory Operations to identify gaps with respect to Current Regulatory Guidelines and procedure followed on shop floor against that specified in SOPs.


Executive - Quality Control

Pfizer Limited
08.2012 - 03.2015
  • Collaborated with back-office team members to facilitate seamless business execution. Actively involved in introduction of new products with reduced average weights / change in packing material resulting in business profit by 20%.
  • Prepared Stability Study Protocol and various reports such final trend /APQR/Interim / Investigation for stability studies.
  • Incubation / withdrawal / testing / reporting of Stability samples.
  • Implemented testing of various types of samples manufactured at Pilot plant as well as raw material as part of Alternate Vendor Development.
  • Prepared and successfully executed Analytical Method Validation / Verification Protocols along with maintenance of SOPs.

Education

B. Pharma -

PES Rajaram & Tarabai Bandekar College of Pharmacy
Goa
07.2008 - 08.2012

Skills

    TrackWise QMS

    CipDox Software

    LMS System

    MS Office

    Power BI

    Tableau

    SQL

    Communication

    Animation

    Collaboration

    Problem-solving

    Adaptability

Accomplishments

  • Developed in-house method for testing of Vitamin B12 content in multivitamin capsules.
  • Developed method for analysis of Bexarotene content in Antacid formulation as a part of Formulation and Development.
  • Involved in Average Weight Reduction project of products manufactured at unit from 100mg to 70mg tablets and being awarded for the same.

Additional Information

  • REGISTERED PHARMACIST – Goa State Pharmacy Council

Certification

Google / Data Analytics Professional Certificate, Coursera, Feb 2023 to June 2023.

Online Certifications

Completed extensive six month job-ready Google Career Certificate Training and Udemy Certification training on Power BI and Tableau. Demonstrated hands-on experience with data cleaning, data visualization, interpreting and communicating data analytics findings.

Total Years of Experience

12 years and 11 months.

Timeline

Google / Data Analytics Professional Certificate, Coursera, Feb 2023 to June 2023.

06-2023

Tableau 2022 A-Z: Hands-On Tableau Training for Data Science, Udemy, Oct 2022 to Feb 2023

02-2023

Complete Introduction to Microsoft Powe BI [2022 Edition], Udemy, May 2022 - June 2022

06-2022

Deputy Manager - Global CAPA

Cipla Limited
06.2015 - Current

Executive - Quality Control

Pfizer Limited
08.2012 - 03.2015

B. Pharma -

PES Rajaram & Tarabai Bandekar College of Pharmacy
07.2008 - 08.2012

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Dipika Manna SarkarDeputy Manager - Global CAPA