Amol Vibhute
Ponda
Summary
Dynamic Quality Assurance professional with extensive expertise in Manufacturing Execution Systems (MES) and Project Management. Acknowledged for exemplary performance at Encube Ethicals Pvt. Ltd, achieving successful implementation of PAS-X within 13 months. Collaborative leader with remarkable problem-solving abilities, committed to enhancing Quality and optimizing processes in high-pressure environments.
Overview
13
13
years of professional experience
Work History
Deputy Manager Quality Assurance
Encube Ethicals Pvt. Ltd
Ponda
02.2018 - Current
- Facilitated MES PAS-X implementation at manufacturing site as core team member.
- Prepared, executed, and reviewed validation documentation for project compliance.
- Participated in FAT and SAT alongside Werum team to validate system functionality.
- Developed MBR and ESP within PAS-X, ensuring adherence to specifications.
- Configured master data in Werum PAS-X to align with operational requirements.
- Conducted SAP and L2 system integration testing to ensure seamless connectivity.
- Executed OQ and PQ tests, verifying system readiness before production launch.
- Managed quality management system activities, including CAPAs and root cause analyses.
- Worked closely with customers to understand needs and resolve diverse issues.
Sr. Executive
Cipla Ltd.
Madgaon
07.2015 - 02.2018
- Responsible for conducting in-process quality assurance (IPQA) activities, which include line clearance and sampling.
- Responsible for monitoring validation batches and sampling.
- Responsible for handling of Rejected raw & packing material and finished products at unit level.
- Handling of Data logger related activities as per requirement.
- To review all quality document and logs on monthly basis.
- Resolving shop floor quality-related issues on day-to-day basis.
- Responsible for managing shifts of IPQA personnel.
- Participate in the investigation of Deviation & Market complaints. Based on investigation appropriate CAPA is proposed.
- Participating in Regulatory/Customer Audits.
- Participating to assure that appropriate calibration & preventive maintenance of equipment & instruments are conducted as per schedule.
- Preparation of Pack line validation report, protocol, and validation summary.
- Review of executed BPR for release and dispatch of batches on a routine basis.
- Identify critical procedures and perform Unit operations for simplification of the process.
- Batch document review and in-process checks: Review of master batch manufacturing and batch packing record.
- Review of online and executed BMR and BPR.
- Participate in the Investigation of Deviation related to discrepancies, in-process test failure, self-inspection & unit operation.
- Review of executed validation reports.
Officer Quality Assurance
Indoco Remedies Pvt. Ltd
Madgaon
02.2014 - 07.2015
- Responsible for in-process quality assurance activities such as line clearance, sampling, and monitoring validation batches.
- To review all quality document and logs on monthly basis.
- Resolving shop floor quality related issues on day-to-day basis.
- Participate in investigating deviations related to discrepancies, in-process test failures, self-inspections, and unit operations, and market complaints. Based on the investigation findings, appropriate corrective and preventive actions (CAPA) are proposed.
- Review of the executed batch production record for the release and dispatch of batches on a routine basis.
- Review of the Master Batch Manufacturing Record, Batch Production Record, and Standard Operating Procedures.
Officer Quality Assurance
Encube Ethicals Pvt. Ltd
Ponda
02.2012 - 02.2014
- Responsible for in-process quality assurance activities such as line clearance, sampling, and monitoring validation batches.
- To review all quality document and logs on monthly basis.
- Resolving shop floor quality related issues on day-to-day basis.
- Participate in investigating deviations related to discrepancies, in-process test failures, self-inspections, and unit operations, and market complaints. Based on the investigation findings, appropriate corrective and preventive actions (CAPA) are proposed.
- Review of the executed batch production record for the release and dispatch of batches on a routine basis.
- Review of the Master Batch Manufacturing Record, Batch Production Record, and Standard Operating Procedures.
- Awarded two times for Outstanding Quality Performer in year 2021-2022 and 2022-2023.
- Got MD's award for successfully implementing of Manufacturing Execution System (PAS|X Application) within 13 months of short period in year 2023-2024.
Education
Bachelor of Pharmacy -
Ashokrao Mane College of Pharmacy
Kolhapur, Maharashtra05.2011
Diploma -
Government College of Pharmacy
Karad, Maharashtra05.2008
H.S.C (12th) -
Yashwantrao Chavan College of Science
Karad, Maharashtra05.2006
SSC -
Mahatma Gandhi Vidyalaya
Kadegaon, Maharashtra05.2004
Skills
- Manufacturing Execution System (MES)
- Strong process knowledge
- Project management
- Process optimization
- Teamwork
- Ability to work under pressure
- Team-oriented leader
- Problem-solving skills
Additional Information
12+ years of experience in Quality Assurance.
Awards
- Awarded three consecutive years for Outstanding Quality Performer in the years 2021-2022, 2022-2023, and 2023-2024
- Got MD's award for successfully implementing the Manufacturing Execution System (PAS)|X Application within a short period in the year 2023-2024
Languages
- English
- Marathi
- Hindi
- Konkani
Personal Information
- Age: 35
- Father's Name: Mr. Baban Vibhute
- Date of Birth: 20/07/1988
- Nationality: Indian
- Marital Status: Married
References
References available upon request.
Timeline
Deputy Manager Quality Assurance
Encube Ethicals Pvt. Ltd
02.2018 - Current
Sr. Executive
Cipla Ltd.
07.2015 - 02.2018
Officer Quality Assurance
Indoco Remedies Pvt. Ltd
02.2014 - 07.2015
Officer Quality Assurance
Encube Ethicals Pvt. Ltd
02.2012 - 02.2014
Bachelor of Pharmacy -
Ashokrao Mane College of Pharmacy
Diploma -
Government College of Pharmacy
H.S.C (12th) -
Yashwantrao Chavan College of Science
SSC -
Mahatma Gandhi Vidyalaya
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