Track-Wise
Shrikant Baburao Phatate
Manager - Quality
Nashik
Summary
To attain responsible and a credential position in an organization, which offers an eminent opportunity for my skill to explore and where my ability and knowledge are of full use to the organization. Interest Areas Quality Control, QA and CQA. I have total 15 Years of Experience in the field of Quality Control. Currently working in Viatris (Mylan laboratories Ltd) Nasik (division- Oral dosage forms Tablets & Capsules) from 11th March 2011 to till date. Previously worked in Ipca Ltd, Dadra Nagar Haveli as QC-Officer from Sept 2009 to Feb 2011 and Vapi Care Pharma PVT LTD in Vapi from Nov 2008 to Aug 2009.
Overview
16
16
years of professional experience
2
2
years of post-secondary education
3
3
Languages
Work History
Quality Assurance Manager
Viatris
Nashik
12.2023 - Current
- Assured timely assessment of Commpendia updates.
- Ensuring risk assessment for nitrosamine impurities.
- Approval of R & D (New product) specification and test procedures.
- Approval of revisions for specification and test procedures.
Team Leader
Viatris (Mylan Laboratories)
Nashik
09.2022 - 12.2023
- Lead of 57 team members in Stability Section of Quality Control
- Responsible for Laboratory investigations like OOS/OOT/ QIA/ Invalid
- Participate in manufacturing investigations as part of cross functional team
- Responsible for determination and effective implementation of CAPA'S
- Responsible for evaluation of CAPA effectiveness check
- Responsible for trend assessment of laboratory errors
- Responsible for review of Change Control and co-ordinate with quality assurance, analytical development and regulatory team for early implementation of change
- Responsible for review of analytical test procedure and standard operating procedures
- Responsible for review of quarterly trend of laboratory and manufacturing investigation
- Responsible to participate in monthly Quality System Review by management and implementation of actions pertaining to meeting
- Responsible for review of APQR
- Responsible for review of cleaning validation protocol and reports
- Responsible for timely incubation, withdrawal and testing of stability samples
- Responsible for review and sharing stability reports, trend analysis with R&D, RA, and project initiator
- Reinterpretation of Analytical Report
- Responsible for preparation and review of graphical Trend chart of Stability batches
- Recent additional responsibility: Method transfer for nitrosamine impurities.
- Conducted training and mentored team members to promote productivity and commitment to friendly service.
- Established open and professional relationships with team members to achieve quick resolutions for various issues.
- Mentored and guided employees to foster proper completion of assigned duties.
- Supervised team members to confirm compliance with set procedures and quality requirements.
- Worked with team to identify areas of improvement and devised solutions based on findings.
- Monitored team performance and provided constructive feedback to increase productivity and maintain quality standards.
- Communicated KPIs outlined in annual plan to inform employees of expectations and deliverables.
- Held weekly team meetings to inform team members on company news and updates.
- Evaluated staff performance and provided coaching to address inefficiencies.
Team Leader
12.2015 - 08.2022
Group Leader
01.2013 - 11.2015
- Work as group leader of Stability section and managed more 20 people in a team
- Daily planning of stability samples in LIMS
- Initiation of laboratory investigation like Invalid and QIA and Deviation in track Wise
- Checking of Daily Lab Compliance Activity
- Ensure GDP & GLP Practice in laboratory
- Responsible to ensure all time audit readiness of quality control laboratory.
Sr. Chemist Quality Control
01.2011 - 01.2013
- Analytical testing of stability samples, test like Assay, Dissolution, Related substances test, Water content, Hardness Friability, content Uniformity etc
- Assist to group leader in planning and maintain Laboratory.
Officer
Ipca
09.2009 - 02.2011
- Analytical testing of stability samples, test like Assay, Dissolution, Related substances test, Water content, Hardness Friability, content Uniformity etc
- Assist to group leader in planning and maintain Laboratory.
Team Lead
Chemist, Vapi Care Pharma Pvt. LTD
11.2008 - 08.2009
- In Commercial Release for Quality Control
- Responsible for Laboratory investigations like OOS/OOT/ QIA/ Invalid
- Participate in manufacturing investigations as part of cross functional team
- Responsible for handling of market complaints
- Responsible for co-ordination and closure of affiliate site investigations
- Responsible for evaluation of CAPA effectiveness check
- Responsible for trend assessment of laboratory errors
- Responsible for review of Change Control and co-ordinate with quality assurance, analytical development and regulatory team for early implementation of change
- Responsible for review of analytical test procedure and standard operating procedures
- Responsible for review of quarterly trend of laboratory and manufacturing investigation
- Responsible for review of APQR
- Responsible for timely Release and co-ordination with IPQA, Supply chain management team
- Responsible for Method improvements and reduction of release time
- Reduced laboratory errors year on year by effective implementation of CAPA'S
- Reduced finished Product average release time from 10 days to 6 Days
- Responsible to review of cleaning validation protocol and reports
- Responsible for trend assessment of laboratory investigation and Graphical presentation, training and necessary CAPA
- Responsible to participate in monthly Quality System Review by management and implementation of actions pertaining to meeting., Analytical testing of Raw Material, Packing Material and Finished Goods, test like Assay, Dissolution, Related substances test, Water content, Hardness Friability, content Uniformity etc
- Exposure to national & international audits:
- Exposed to various National and International audits such as: USFDA, MHRA,WHO, HPRA,TGA
- Regards
- Shrikant Baburao Phatate Page 2 of 2
- Conducted training and mentored team members to promote productivity and commitment to friendly service.
- Developed monthly and daily production output plans to deliver on customer service and financial metrics.
- Held weekly team meetings to inform team members on company news and updates.
Education
M. Sc. Organic Chemistry -
Shri. Chhatrapati Shivaji College
Omerga 07.2006 - 07.2008
Skills
Expert in OperationHPLCUV SpectrophotometerDissolution ApparatusFriabilityKF Auto titratorDisintegration tester etcTrack WiseLIMSSAPShrikant Baburao PhatateManager (Quality)
Software
LIMS
SAP
Empower 3
Timeline
Quality Assurance Manager
Viatris
12.2023 - Current
Team Leader
Viatris (Mylan Laboratories)
09.2022 - 12.2023
Team Leader
12.2015 - 08.2022
Group Leader
01.2013 - 11.2015
Sr. Chemist Quality Control
01.2011 - 01.2013
Officer
Ipca
09.2009 - 02.2011
Team Lead
Chemist, Vapi Care Pharma Pvt. LTD
11.2008 - 08.2009
M. Sc. Organic Chemistry -
Shri. Chhatrapati Shivaji College
07.2006 - 07.2008