Ashish Jamgade
Quality Project Manager
Hyderabad
Summary
Results-driven Project Management Professional (PMP®) with over 13 years of progressive work experience in the biopharmaceutical/pharmaceutical industry. Skilled in the Project Management Life Cycle, I have a proven track record of analyzing, planning, developing, and tracking project plans to achieve strategic business goals. Expertise in equipment qualification activities aligned with ICH, local procedures, cGMP, and best practices. Strong communication skills delivering coherent observations to internal and external business partners at all levels. Excellent time management skills for efficient project execution.
Overview
14
14
years of professional experience
7
7
years of post-secondary education
1
1
Certification
Work History
Quality Assurance Project Manager
Dr. Reddy's Laboratories
11.2020 - Current
- Planning, managing, and coordinating all activities for end-to-end process of CDMO, sourcing and procurement of necessary materials and supplies needed to meet the changing levels of product demand.
- Created dashboard presentations, for QMS reports, and weekly project status updates in management review.
- Drove continuous improvement initiatives within the QA department, resulting in measurable enhancements to product quality levels over time.
- Led cross-functional teams for successful project completion, ensuring timely delivery of high-quality products like DOCHUB and ELN implementation.
- Coordination with the Business partners/CMOs to streamline the project execution as per plan.
- Leading a team of Cross functional team for implementation of QMS application.
- Ensure alignment with strategic objectives through go-no-go decisions at phase gate meetings with CFTs.
Principal Scientist
Innovative Drug Research Solution Pvt Ltd.
10.2015 - 10.2020
- Facilitated regular knowledge-sharing sessions among team members to foster collaboration and alignment around shared goals.
- Achieved successful project outcomes by leading cross-functional research teams and leveraging scientific expertise.
- Played a pivotal role in procuring and conducting Factory Acceptance Testing (FAT) for diverse laboratory equipment, ensuring operational efficiency.
- Lead the CSV projects for various software application for R and D set up.
- Designing launching strategy for various dosage forms for India market.
Senior Executive-DQA
Syngene International Ltd.
08.2013 - 10.2015
- Executed digital transformation strategy that modernized paper based system like ELN improving overall productivity.
- Established and qualified the dedicated stability chamber for the client.
- Streamlined and monitored quality programs to alleviate overdue compliance activities.
- Review and approval of Method validation and Method Transfer protocols and reports for the client
Executive-DQA
Micro labs Pvt Ltd.
08.2011 - 07.2013
- Preparation of specification and standard test procedure
- Review of Method validation of protocols and reports
- Conducting internal audits and assist the team to close the observation.
- Collaboration with R&D, QA/QC and plant team for execution of Zone IV stability study along with alternate pack style development.
Officer-ADL
Plethico Pharmaceutical
03.2011 - 08.2011
- Method development for Dissolution , Assay and RS method.
- Finished Product Analysis as per schedule.
- Raw material analysis as per the approved STP
- Calibration of Instruments as per the calibration schedule
Education
Bachelor of Pharmacy - Pharmaceutical Science
Amravati University
Amravati, MH 01.2005 - 01.2009
Master of Pharmacy - Quality Assurance, Pharmaceutical Science
Amravati University
Amravati, MH 01.2009 - 01.2011
Certificate course - Statistical Quality Control and Operational Research
Indian Statistical Institute
Bangalore, KA 01.2015 - 01.2016
Skills
Conflict Management
Accomplishments
- Collaborated with team of 10+ in the development of QMS system for the IDRS Labs.
- Implemented DOCHUB (Dochub Management system) in R and D by managing Cross functional team.
- Leading a team of 20+ members for the implementation of QMS 2.0 in current organization.
- Significantly contributed in developing and implementing the online calculation report templates in Chromeleon application in IDRS Labs.
Certification
Project Management Professional
Timeline
Project Management Professional
11-2024
Quality Assurance Project Manager
Dr. Reddy's Laboratories
11.2020 - Current
Principal Scientist
Innovative Drug Research Solution Pvt Ltd.
10.2015 - 10.2020
Certificate course - Statistical Quality Control and Operational Research
Indian Statistical Institute
01.2015 - 01.2016
Senior Executive-DQA
Syngene International Ltd.
08.2013 - 10.2015
Executive-DQA
Micro labs Pvt Ltd.
08.2011 - 07.2013
Officer-ADL
Plethico Pharmaceutical
03.2011 - 08.2011
Master of Pharmacy - Quality Assurance, Pharmaceutical Science
Amravati University
01.2009 - 01.2011
Bachelor of Pharmacy - Pharmaceutical Science
Amravati University
01.2005 - 01.2009
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