Manish Kushwaha
Quality Assurance
Mapusa
Summary
Looking for a challenging career with an organization where I can apply my skills and knowledge so that I can contribute fully to the growth and development of the organization, while working in an innovative and growth oriented environment. Committed Quality Assurance with 15 years of extensive experience in quality management. Proven background using research methodologies and techniques to conduct data analysis and provide recommendations. Working knowledge of internal and outside audit processes and responses to take action immediately.
Overview
16
16
years of professional experience
4
4
years of post-secondary education
Work History
Quality Assurance Manager
Glenmark Pharmaceutical Ltd.
Goa
06.2011 - Current
- Handling of manufacturing quality assurance activity
- Responsible for quality compliances
- Ensure compliance to documentation practices as data integrity and reliability
- Responsible for implementation of Quality systems and SOP compliance in shop floor
- Electronic data review of manufacturing system
- Preparation, review and implementation of protocol and SOP
- Sample management
- Review and investigate OOS, incident, market complaint
- Responsible for initiation & review of change control/Incident/CAPA as applicable
- Execution and monitoring of process validation batches
- Execution and monitoring of hold time study
- To check and perform SAP and Track-wise related activity and compliances
- Responsible to ensure the team members are trained by providing training on relevant SOPs
- Responsible for preparation of observation response of regulatory agencies and customers
- Responsible for review and verification of executed Batch Production Records (BPRs)
- Ensuring the submission of Batch Production Records (BPRs) to QP
- Review of quarantine dispatch request form (Q-form) for Europe QP approval
- Responsible for review and support to production and R&D for technology transfer of new products execution in the facility
- Perform review of “Format Control Audit Log” monthly reports on a monthly basis for IPQA section of QA department.
Quality Assurance Officer
Macleods Pharmaceuticals Ltd.
Mumbai
09.2008 - 06.2011
- Organization of Quality Assurance functions
- Responsible for quality aspects of development products
- Monitoring & Maintaining GMP in Shop floor
- To check the In-process quality assurance in Tablet, Capsule and Liquid section
- Timely sampling of finished product and validation batches
- Coordinating in validation activities- sampling during validation at different stages of Manufacturing Process
- Training – to new joiners for various activities on shop floor, new documentation practices and changes on shop floor
- Coordinate with the quality control department and get the Validation & In-process samples tested as per the specification
- Audit preparation- conducting internal audits, compliance of non- cGMPs on shop floor at regular intervals, reviewing documents etc
- Responsible to follow and implement SOPs and cGMP standards
- Line clearance & in-process checks in every stage
- Calibration of In-process Instruments
- Review of Online BMR & BPR.
Education
Bachelor of Pharmacy - Pharmacy
Guru Ramdas Khalsa Institute of Science And Technology Jabalpur (M.P.)
Jabalpur 07.2004 - 05.2008
Skills
Expertise on manufacturing Quality compliance, continue process improvement,
NDMA
Batch certification
Manufacturing investigation
Accomplishments
- Awarded by SPOT award five times for valuable contribution towards living and championing the organizational values
- Awarded by best employee of the year 2019
- Awarded by most vigilant team of the year 2019 and 2022
- Awarded four times in UXCELL award
- Value adding & cost saving project have been implemented personally & some under small group activity
Correspondenceaddress
Manish Kumar Kushwaha, A block, Flat no. A-202, Sai greens complex cunchelim, Mapusa, 403507
Additionalresponsibilities
- Lead time management – involved in reducing lead time during manufacturing activities, analyzing it and generating data for that
- Reduce study and cost saving project by generating data and revise the BPR and specification
- Prepare daily activity report for monitoring of QA activity
- SAP t code modification related to work
- Process monitoring
- Project management
Otherpursuits
- Active participation during USFDA, MHRA, ANVISA, WHO, QP and other regulatory audit
- Attended Training on ‘Unit Dose sampling’ in Dec. 2010 arranged by Sanni Raju, President, GlobePharma, NewJersey
- Attended 3 days training program by Fred Rowley on Granulation, compression and coating
- Part of Lean six sigma certification and implemented cost saving projects
- Attended FDA webinar 'Understanding FDA inspection and data webinar' on 09/06/2023
Personal Information
- Father's Name: Mr. Ram Sharan Kushwaha
- Date of Birth: 09/14/85
- Nationality: Indian
Languagesproficiencies
English, Hindi
Disclaimer
Above all the information provided by me is true to the best of my knowledge and I am full responsible for it. If I will select in your reputed concern, I shall be very thankful to your kind authority. I will perform my duty sincerely and honestly.
Timeline
Quality Assurance Manager
Glenmark Pharmaceutical Ltd.
06.2011 - Current
Quality Assurance Officer
Macleods Pharmaceuticals Ltd.
09.2008 - 06.2011
Bachelor of Pharmacy - Pharmacy
Guru Ramdas Khalsa Institute of Science And Technology Jabalpur (M.P.)
07.2004 - 05.2008
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