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, MH01.2014
Master of Science - Biotechnology
Bharati Vidyapeeth University
Pune03.2009
Diploma in German - Foreign Language
Pune University
Pune06.2007
Bachelor of Science - Zoology
Pune University
Pune04.2007
Certificate Course in German - Foreign Language
Pune University
Pune06.2006
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
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