SUSHANT DESHMANE
Nashik
Summary
Considered quality as the prime goal and timely gets updated for the changes in the regulatory guidelines. Understand and simplifies the procedures to minimize the errors. Holistically investigates the failures to implement changes effective to avoid any future circumstances. Highly enthusiastic and hard working team player and keep the right temperament to achieve big goals with utter determination.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Executive
Emcure Pharmaceutical limited
Ahemdabad
12.2021 - Current
- Conducted microbiology analysis including bioburden testing, endotoxin testing, microbial identification, Biological Indicator testing, sterility checks, and growth promotion of media as required.
- Carry out environmental monitoring including viable and non-viable particulate monitoring and water and gas system monitoring in cleanroom areas in the manufacturing facility.
- Participated in the technical transfer / validation / verification of microbiological and analytical testing procedures.
- Training and developing the team in microbiological test methods, aseptic training and contamination control of the facility to ensure the highest level of quality and practices in support of our patients.
- knowledge of all cGMP, company specifications, procedures and guidelines such as PDA, ISO, 21 CFR PART 210, 211, PART 11, EU GMP ANNEX-1 AND ANNEX-11.
- Handled Investigation of Out of Specification (OOS) and Out of Trend (OOT), Non-Conformances and actively lead subsequent corrective actions.
- Own and support Change Controls and Change Actions.
- Supported Audit Readiness and participate in Audits. USFDA, EUGMP, health Canada, ANVISA.
- Supported Commissioning Qualification Validation activities
- Supported instrument calibration and maintenance
- Performed GEMBA Walks of the laboratory and cleanroom areas.
- Use Global LIMS/MODA or other computerized systems for entering and approving test results as applicable.
- Scheduling and coordinating the QC Microbiology team and lab activities. Supporting analytical instrument qualification.
- Leading/supporting projects and project delivery.
- Proven ability through working across teams focusing on meeting and tracking to schedules and embracing and interdependent work culture as an agile team member.
- Promoting a culture where diversity and inclusion is part of the DNA.
- Collaborates with cross-functional teams to deliver the site objectives.
- Work under minimal supervision and on own initiative.
- Act as a point of contact for Lead Analyst and Area Lead.
Executive
Alembic Pharmaceuticals limited
Vadodara
08.2019 - 09.2021
Officer
Emcure Pharmaceuticals limited
Pune
05.2016 - 03.2019
Senior Officer
wockhardt pharmaceuticals limited
aurangabad
06.2014 - 05.2016
Education
MSC BIOTECHNOLOGY -
University of Pune
07.2013
BSC BIOTECHNOLOGY -
UNIVERSITY OF PUNE
06.2011
Skills
- Expert in making presentation, excel, budget, gantt chart
- Ability to Work in a Team and under pressure
- Strong Communication Skills
- Risk Management
- Quality Management
- Strategy Development
- Leadership/communication skills
- Analytical Skills
- Administrative Skills
Accomplishments
- Recognized as key player in functioning new site within short period of time.
Certification
- received various ceritificates on gmp training, machine learning, and csv activities through online platform like linkedin learning, udemy.
References
References available upon request.
Timeline
Executive
Emcure Pharmaceutical limited
12.2021 - Current
Executive
Alembic Pharmaceuticals limited
08.2019 - 09.2021
Officer
Emcure Pharmaceuticals limited
05.2016 - 03.2019
Senior Officer
wockhardt pharmaceuticals limited
06.2014 - 05.2016
MSC BIOTECHNOLOGY -
University of Pune
BSC BIOTECHNOLOGY -
UNIVERSITY OF PUNE
- received various ceritificates on gmp training, machine learning, and csv activities through online platform like linkedin learning, udemy.
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