Malay Doshi
Expertise In QC and QA
Ahmedabad
Summary
Seeking quality level Assignment from last 10 years in the domain of QC and QA with all leading organisation of high repute preferably in pharmaceuticals sector, where I can contribute my potential ability to the organisation’s success.
Overview
10
10
years of professional experience
2
2
years of post-secondary education
2
2
Languages
Work History
Senior Exexcutive
Zydus Lifesciences
Ahmedabad
12.2020 - 02.2024
- Handling all documentation regarding Analytical QC/QA and QMS
- Executing and implementing Change Control, Deviation, OOS, CAPA, Complaint Analysis, Non-Conformity, APQR & Internal audits, Deviations, OOT, Market complaints, Returns, Recall, Risk Management.
- Member of QUEST and Cost Savings Initiatives: Participating in continuous improvement initiatives, collaborating with colleagues to identify opportunities for enhancement. Also, contributing to initiatives aimed at optimising costs and improving operational efficiency.
- Review of Electronic Audit Trails with raw data and to ensure data reliability.
- Review, Approval and Closure of QMS Document timely to release batches.
- Provision of site acceptance for change control as per need of department.
- Preparation, review and approval of quality documents (SOPs, planner, schedule etc.)
- Review and Approval of Process validation/Study - Protocol and Reports.
- Successfully managed budgets and allocated resources to maximize productivity and profitability.
- Established team priorities, maintained schedules and monitored performance.
- Qualified auditor and periodically conduct self-inspection across the cross-function department to evaluate the gaps and implement preventive action.
- Performing Self-inspection, document findings, identifies CAPA and assist department for implementation.
- Audit trail Review for Electronic Software system (LabX, Lab solution, Empower, Chromeleon etc).
- Report review of Method Verification (Life Cycle of Analytical Method).
- Responsible for review of Method Validation/Transfer/Equivalency study documents/Validation protocol and Report
Senior Research Associate
Lambda Therapeutics Limited
Ahmedabad
09.2019 - 09.2020
- Responsible for quality management system like OOC, Lab Incidence, Laboratory investigations Recording, reviewing, trending, CAPA implementing and effectiveness check.
- Served as the department's training coordinator, organizing and delivering training sessions to ensure staff competence and compliance with procedures.
- To review and approve the COA received from QC for Finished Product.
- Preventive role ensuring reduction in lab errors and relevant QMS.
- Reviewing Batch record, STM, SOPs, stability testing data and auditing laboratory note books and instrument calibration records
- Provide comprehensive formal and informal leadership to promote work environment and communicate overall business expectations to QC
- Supervise chemists to include, but not limited to overseeing testing, check progress of samples for release and ensure assigned tasks are performed on timely manner
- Work distribution among chemists based on priorities
- Interact with other departments for testing information required for methods and or proper documentations.
- Monitoring stocks of reagents and laboratory supplies
- Train new employees on basic laboratory techniques.
Executive
Torrent Pharmaceuticals Limited
Ahmedabad
04.2015 - 08.2019
- Familiarity with method validation, method development, technical writing, & analytical chemistry in GLP or cGMP analytical laboratory environment.
- Executed release and stability Quality Control tests for both in-process and finished manufactured products, as well as Intermediate Precision for new products
- Performed Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), Fourier Transform Infrared Spectrometry (FTIR), dissolution, disintegration, hardness, and moisture content.
- Operated, troubleshot, calibrated, and repaired equipment and instrumentation.
- Provided training to juniors on new methods, operation of dissolution equipment, and dissolution calibration.
- Maintained and updated all records and lab books as well as training records; presented results to stakeholders and drafted reports.
- Responsible for preparing and revising Standard Operating Procedures to maintain compliance and efficiency.
- Involved in the implementation and upgrading of new analytical software, ensuring seamless integration and compliance with regulatory requirements.
- Managed cross-functional teams for successful project completion within budgetary constraints and deadlines.
Sr. Quality Analyst
Green Cross Laboratory
Ahmedabad
04.2012 - 09.2016
- Work in product development in lab as senior analyst for trials and research on new products for various regulated markets.
- And also worked in product registration and sample acceptance.
- Deep knowledge of various of effectiveness products.
- Worked at various projects submission and performed initial qualification/ validation/calibration/performance verification for numerous instruments.
- Masters documentation for SOP/STP accordingly.
- Collaborated with cross-functional teams to establish quality standards, ensuring alignment with organisational goals and objectives.
- Conducted training and qualification programs for new joiners and analysts from other sites, ensuring proficiency in laboratory procedures and equipment operation enforce quality policies and directives, promoting a culture of quality and continuous improvement.
- Performed tests and inspections to conform to established standards.
Education
M.S.C - Chemistry
NIMS University
Rajasthan, India 01.2017 - 1 2019
B.S.C - Chemistry
Gujarat University
Ahmedabad, India 06.2009 - 07.2011
Medical Laboratory Technician -
Gujarat University
04.2012 - 6 2013
Skills
Successfully faced and Experienced in Audits like MHRA, WHO GMP, USFDA, TGA, ANVISA
undefinedInstruments
Well versed in all modern instrumentation such as
HPLC, GC, FTIR, KF, UV Visible Spectrophotometer, Auto-Titrator, Solo VP, Dissolution, Ion Chromatography, Refractometer.
Personal Information
- Date of Birth: 10/11/1990
- Gender: Male
- Marital Status: Married
Achievement
Implementing LIMS (Laboratory Information Management System)version3.4.0.E at
Zydus Biologics Site marks a significant step towards achieving a paperless environment.
Disclaimer
I hereby declare that the information furnished above is true to the best of my knowledge
Yours Sincerely,
Malay Doshi
Timeline
Senior Exexcutive
Zydus Lifesciences
12.2020 - 02.2024
Senior Research Associate
Lambda Therapeutics Limited
09.2019 - 09.2020
M.S.C - Chemistry
NIMS University
01.2017 - 1 2019
Executive
Torrent Pharmaceuticals Limited
04.2015 - 08.2019
Medical Laboratory Technician -
Gujarat University
04.2012 - 6 2013
Sr. Quality Analyst
Green Cross Laboratory
04.2012 - 09.2016
B.S.C - Chemistry
Gujarat University
06.2009 - 07.2011
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