Summary
Overview
Work History
Education
Skills
Accomplishments
Hobbies and Interests
Additional Information - Trainings Attended
Languages
Timeline
Generic

Saurabh Dole

Thane

Summary

Dedicated professional offering several years of experience. Effective at independently planning and managing diverse business relationships. Proficient in time management with disciplined execution strategy. Demonstrated strong organizational skills and communication abilities.

Overview

15
15
years of professional experience

Work History

Executive QA

Johnson & Johnson Pvt Ltd
Mumbai
11.2015 - Current
  • Managed quality records (NCs, CAPAs, Change Controls) according to established procedures.
  • Maintained oversight on timely resolution and handling of quality records.
  • Acted as super user for systems supporting NC, CAPA, and Change Control management.
  • Reviewed documents (SOPs, WIs) for compliance with applicable regulatory standards.
  • Performed audits of document archival processes against standard operating procedures.
  • Engaged in internal auditing programs to ensure follow-up on CAPA actions.
  • Supported new equipment qualification and trained teams on quality system SOPs.
  • Process Owner and Department Co-originator for Record Management Process.
  • Responsible for the Inspection Management program.
  • Data steward for collating and interpreting data for management review.
  • Core team member for data integrity assessment on-site.
  • Responsible for SMF and quality system SOPs.

Officer QA

Emcure Pharmaceuticals Ltd
Pune
10.2013 - 11.2015
  • Review of Change controls, Deviations, CAPAs, NPPs, Laboratory Investigations and other quality system documents.
  • Successful support during technical audits conducted by regulatory authorities and contract givers at different sites.
  • Review of Batch Records, Process validation protocol & reports pertaining to ANDA & DMF submission at solid orals plant, sterile manufacturing plant, Oncology plant and API plant.
  • Review of Microbiological records and reports.
  • Review of equipment / instrument qualification documents.
  • Successfully assisted in compilation of protocol and report pertaining to the CQ activities.
  • Participation in Self Inspection.
  • Preparation of SOPs pertaining to Corporate Quality functions.
  • Review of Microbiological Validation data. Preparation of protocol and reports pertaining to validation.
  • Core team member for implementation of TrackWise system.

Officer – QA Validation

Zydus Hospira Oncology Pvt. Ltd
Ahmedabad
04.2010 - 10.2013
  • To execute Re-qualification activities as per routine Re-qualification schedule.
  • Involved in the new project activities viz. FAT, commissioning, IQ, OQ and PQ of the new equipment and utilities.
  • Involved in the process validation & cleaning validation activities of the product.
  • Involved in the thermal qualification of Equipments.
  • Involved in temperature mapping studies of various areas and Equipments.
  • Participation in Media Fills.
  • Involved in HVAC qualification of the controlled areas.
  • Involved in the Integrity testing and Air velocity testing of LAF's, Cytosafety cabinet, Dynamic Hatch, RABS etc.
  • Involved in the protocol preparation and execution of IQ, OQ and PQ of new Equipments.
  • To perform the shipment validation for the product shipment.
  • To check, compile, document and summarize the validation activities in a validation summary report.
  • Core team member for commissioning and installation of Parental Line 2 on site.

Education

Post Graduate Diploma - Operations Management

Prin. L. N. Welingkar Institute of Management Development & Research
Mumbai, MH
01.2014

Master of Science - Biotechnology

Bharati Vidyapeeth University
Pune
03.2009

Diploma in German - Foreign Language

Pune University
Pune
06.2007

Bachelor of Science - Zoology

Pune University
Pune
04.2007

Certificate Course in German - Foreign Language

Pune University
Pune
06.2006

Skills

  • Quality assurance processes
  • Regulatory compliance oversight
  • Document management systems
  • Audit and change control
  • CAPA implementation strategies
  • Data analysis techniques
  • Process validation expertise
  • SOP creation and equipment qualification
  • Problem-solving abilities
  • Communication proficiency with stakeholders
  • Team collaboration and leadership capabilities
  • Training initiatives and negotiation tactics

Accomplishments

  • Audit participation: Anvisa-Brazil, Uganda, Korean FDA, Saudi Arabia, Tunisia, USFDA, EMA and MHRA-UK
  • FPX Project Leadership Workshop: Mr Vijay Srirangam
  • Invited as a guest lecturer for delivering lecture on “GMP in Pharmaceuticals” to M.Sc. Biotechnology students at Rajiv Gandhi Institute of I.T And Biotechnology, Bharati Vidyapeeth Deemed University, Katraj, Pune

Hobbies and Interests

  • Trekking
  • Fond of listening to light Music
  • Sports - Fond of various sports like Cricket, Football, Formula 1
  • Reading Books

Additional Information - Trainings Attended

  • Gurukul's – Shaping for Success: Col Naresh Sinha
  • Gurukul's – Train the Trainer: Mr. Gokul Pabari
  • Gurukul's – INSPIRE (Insights into Superior Interpersonal Skills): Col. Naresh Sinha
  • Empower 3 Software Result Audit Viewer Course – Water Global Services
  • Effective Strategy & Approach for Conducting Internal and External Audits – Mr. Puthucode N Rajamani
  • In-House Trainings: cGMP training, Training of communication and Business skills, Deviation, change control, Packing Module
  • External Trainings: Seminar on USP (Pharmacopeial Education Program, Ahmedabad), Quality Risk Management (Organized by Insight Systems at Thane)

Languages

Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
German
Beginner
A1

Timeline

Executive QA

Johnson & Johnson Pvt Ltd
11.2015 - Current

Officer QA

Emcure Pharmaceuticals Ltd
10.2013 - 11.2015

Officer – QA Validation

Zydus Hospira Oncology Pvt. Ltd
04.2010 - 10.2013

Post Graduate Diploma - Operations Management

Prin. L. N. Welingkar Institute of Management Development & Research

Master of Science - Biotechnology

Bharati Vidyapeeth University

Diploma in German - Foreign Language

Pune University

Bachelor of Science - Zoology

Pune University

Certificate Course in German - Foreign Language

Pune University
Saurabh Dole