Mahesh Dighe
Executive, SME Quality Compliance
Mumbai
Summary
Dedicated Pharmaceutical, Quality and Compliance professional with a history of meeting company goals utilizing consistent and organized practices. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational brand. Excellent interpersonal and communication skills. Big picture focus with excellence in communicating goals and vision to succeed.
Overview
9
9
years of professional experience
Work History
Executive & SME Quality Compliance
Apotex Research Pvt. Ltd
02.2018 - Current
- Review all compendia changes from different publications, supplier driven changes and determine impact on Apotex and 3rd party specifications, methods, test profiles.
- Verify method validation/ equivalencies/ verification / stability reports.
- Perform review on initiated change controls, perform gap assessment between Apotex and different vendor specifications.
- Support and represent in Audits, Internal communication with RA, PV, Procurement, and all sites of Apotex.
- Perform review on provide documents for RA submission, prior approval for all regulatory markets.
- Formed and sustained strategic relationships with clients.
- Implemented training and development programmes for new employees to successfully exceed retention targets.
- Led change management initiatives to drive cultural shifts towards continuous improvement mindsets.
- Proven ability to learn quickly and adapt to new situations.
Officer Quality Assurance
Emcure Pharmaceutical
05.2016 - 01.2018
- Maintained strict adherence to industry regulations, minimizing risk exposure for the organization.
- Reviewed of Quality Control data, Preparation of APQR., performed verification and usage decision in SAP.
- Gathered, organized and input information into digital database.
- Participation in change control, Deviation, Laboratory Investigation and related activities.
- Quality Control, Plant and Warehouse Audit to verify compliance status.
- Internal communication with QA, QC, Warehouse, Production for smoothening operation.
- Submission of data to regulatory by following regulatory commitment.
Jr. Officer Quality Control
Macleods Pharmaceutical
03.2015 - 04.2016
- Performed analysis of Finished products, Raw Materials, Stability samples.
- Maintained database systems to track and analyze operational data for Raw Material, Finish Product Stability sample, Columns retention management.
- Calibration of various Analytical Instruments.
- Preparation & Standardization of Volumetric Solutions and Reagents.
- Conducted regular reviews of operations and identified areas for improvement.
- Provided reporting for forecast analysis and ad-hoc reporting in support of decision-making.
- Frequently inspected production area to verify proper equipment operation.
- Led a team of junior staff members, providing guidance, mentorship, and professional development opportunities.
Education
Master of Science - Pharmaceutical Quality Assurance
Pravara Institute of Pharmacy
Loni, MH 04.2001 -
Bachelor of Science - Pharmacy
Mula Education Societys College Of Pharmacy
Ahmednagar, MH 04.2001 -
Skills
Process Improvements
Strategy Development
Training and Development
Motivation
Quality Assurance
Hiring and Onboarding
Accomplishments
- Part of kaizen project 2023.
- Achieved good results by introducing daily tracker for online tracing of tasks.
Timeline
Executive & SME Quality Compliance
Apotex Research Pvt. Ltd
02.2018 - Current
Officer Quality Assurance
Emcure Pharmaceutical
05.2016 - 01.2018
Jr. Officer Quality Control
Macleods Pharmaceutical
03.2015 - 04.2016
Master of Science - Pharmaceutical Quality Assurance
Pravara Institute of Pharmacy
04.2001 -
Bachelor of Science - Pharmacy
Mula Education Societys College Of Pharmacy
04.2001 -