Dhiraj Dashrath Shirsat
Aurangabad
Summary
Dynamic and results-driven professional seeking a rewarding career in the pharmaceutical sector. Committed to leveraging and enhancing skills in a challenging environment that fosters growth and innovation. Eager to contribute to organizational success while continuously sharpening expertise in the field. Passionate about driving impactful results and embracing new challenges to achieve excellence.
Overview
21
21
years of professional experience
Work History
Assistant General Manager-QA
Viatris (Mylan Laboratories)
01.2016 - Current
- Review of the investigation related to manufacturing & packaging of the product based on the root cause analysis and current regulatory requirement.
- Investigation and review of market complaint in co-ordination with cross functional team.
- Designing, reviewing & monitoring of CAPA, as a result of manufacturing, packaging, market complaint and pre-market supply incident investigation.
- Conducting self-inspection audit to ensure the quality system for all GxP areas (Warehouse, Manufacturing, Packaging, and Engineering) are in place and maintained.
- To provide quality presence and input to Technical Meetings with internal customer and establish good business relationships with clear communication with defines goals.
- Conducting the GAP assessment of departmental SOP against company global policies and their resolution as per applicable regulations.
- Escalate all the potential quality issues and initiate all actions define to resolve the quality issue.
- Assist in evaluation of action items related to change controls associated with manufacturing and packaging areas.
- Facility approved with US FDA, MHRA & MCC.
Sr. Executive
WATSON PHARMACEUTICAL LTD
04.2015 - 01.2016
- Providing quality assurance support to ensure compliance of GMP & regulatory requirements.
- Managing the change request by assessing the quality and regulatory impact from receipt to its closure.
- Providing quality presence and input for finalization of CAPA through technical meeting with clear communication.
- Responsible for leading internal audit and customer audit in coordination with QA head.
- Preparation, training & implementation of SOP related to quality system.
- Review of qualification, process validation protocol & report and ensuring GxP compliance.
- Tracking of internal and external audit findings, CAPA’s, change control, Temporary changes, OOT manually as well as in Track wise system.
- Escalating all potential quality issues and initiate actions define to resolve the quality issue.
- Facility approved with US FDA, MHRA & MCC.
QA Executive
GLAXO SMITH KLINE LTD
08.2012 - 04.2015
- Worked as Operation Quality Lead responsible for handling of quality issue at shopfloor.
- Preparation & timely review of qualification protocols & reports.
- Preparation of Site Validation Master Plan (SVMP).
- To work closely with all departments to ensure site in validated condition as per SVMP.
- Facility complies with cGMP, WHO standards, approved by FDA, ISO 9001 and ISO 14001.
Validation Executive
RANBAXY LAB. LTD.
05.2010 - 07.2012
- Preparation of Qualification calendar, planning & executions of validation task/activities related to equipments and utility.
- Preparation, Review, updation, coordination and execution of Validation protocols for (Equipment, Instrument, system & Utilities (HVAC, Compressed air system, Nitrogen air system, Water system) & completion for closer.
- Preparation of risk assessment for equipment / instrument / system/facility.
- Preparation, review & implementation of validation related master documents, VMP, SOPs & any other written procedural instruction.
- Legacy system gap analysis & closer through remedial plan including Equipment PQ.
- Implementation of current cGMP & GDP practices at work place as per SOP.
- Technical support in new project/facilities execution.
- Harmonization of validation practices.
- Facility complies with cGMP, WHO standards and is approved by Indian FDA, ANVISA and ISO 9001, ISO 14001.
Validation Officer
WOCKHARDT
10.2007 - 05.2010
- Preparation of qualification document like User requirement specification, Design qualification (DQ), Factory acceptance test (FAT), Installation (IQ), operational (OQ) & performance qualification (PQ) for new equipment.
- Performing Factory acceptance test at Machine manufacture site for manufacturing & packing equipment.
- Preparation & up-dation of validation master plan.
- Requalification of manufacturing & packing equipment as on need basis.
- Preparation, execution & compilation of qualification document for new manufacturing facility.
- Preparation of qualification document for New & existing HVAC, LAF and Compressed air.
- Giving training on department SOP like equipment qualification, URS preparation, Validation master plan preparation.
- Facility complies with cGMP, WHO standards and was approved by Indian FDA, USFDA, MHRA, and ISO 9001, ISO 14001
QA Officer
AJANTA PHARMA LTD
03.2005 - 10.2007
- Worked as IPQA section head, responsible for handling of quality issue at shopfloor.
- Worked in Process validation section for tablets & capsule dosage form.
- Preparation, Execution & compilation of process validation protocols & reports for regulatory & non-regulatory market.
- In process control and documentation, co-ordination with production, engineering, quality control, Drug regulatory affairs & other department for documentation like change control, deviation etc.
- Facility complies with cGMP, WHO standards and was approved by Indian FDA, ANVISA, and USFDA.
Education
B. Pharmacy -
Dr. Babasaheb Ambedkar University
Aurangabad, MaharashtraSkills
- Comprehensive problem solving
- Willingness to learn new ideas
- Strong motivation power
- MS Excel, MS Word, E-mail & Internet
Linguistic
Speak, Read and write Comfortably: English, Hindi & Marathi
Exposure to Audit
- US FDA (Viatris/Mylan)
- MHRA (Viatris/Mylan)
- US FDA (Watson pharma)
- US FDA (Wockhardt Ltd)
- MHRA (Wockhardt Ltd)
- ANVISA (Ajanta Pharma)
- SANDOZ (Ranbaxy)
- UKRAINE (Ranbaxy)
- SANOFI AVENTIS (Ranbaxy)
- FDA-India (Ranbaxy)
- PENSA-SPAIN (Ranbaxy)
Machine Qualified
- Bottle Line- Countec.
- Blender: Gansons-70- 300 L
- RMG: Sainath-50 to 400 L
- FBD: Pamglatt-500 L
- Compression Machine: Cadmach- CPD IV-45 PAM- Legacy 6100 (37)
- Coating machine: Gansons- GAC-900(45 – 75) GAC-1200 (120-150)
- Capsule filling M/C.: PAMGLATT- AF40T & AF90T.
- Blister sealing machine: PG-230T etc.
Current Salary
20.00 Lac.
Personal Traits
- Discipline.
- Sincerity.
- Honesty.
- Hard Work.
- Positive Attitude
Interests and Hobbies
Listening Music., Reading newspaper, Making new friends.
Timeline
Assistant General Manager-QA
Viatris (Mylan Laboratories)
01.2016 - Current
Sr. Executive
WATSON PHARMACEUTICAL LTD
04.2015 - 01.2016
QA Executive
GLAXO SMITH KLINE LTD
08.2012 - 04.2015
Validation Executive
RANBAXY LAB. LTD.
05.2010 - 07.2012
Validation Officer
WOCKHARDT
10.2007 - 05.2010
QA Officer
AJANTA PHARMA LTD
03.2005 - 10.2007
B. Pharmacy -
Dr. Babasaheb Ambedkar University