Rahul Nandwalkar
Thane
Summary
Accomplished Senior Executive at BLISS GVS PHARMA LIMITED with expertise in quality management systems and regulatory compliance. Proven track record in conducting successful audits and vendor management, enhancing process validation, and fostering team collaboration. Adept at problem-solving, ensuring compliance, and driving continuous improvement initiatives.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Executive
BLISS GVS PHARMA LIMITED
Mumbai
09.2024 - Current
- Perform internal and external quality audits.
- Host the audits from regulatory, customer and provide appropriate response to audit observation and corrective and preventive action report to regulatory authorities, customers.
- Deliver Functional and GMP Training.
- To evaluate change control request for impact assessment.
- To evaluate deviation for impact and investigation.
- To coordinate with respective stakeholders to understand the purpose and impact of changes.
- To perform categorization of change control, Deviation and proposed remedial actions.
- Ensure remedial actions before closure of QMS.
- Review the CAPA and its effectiveness before closure and report observations.
- Preparation and review of risk assessment as part of QMS event.
- Trending of various QMS processes to identify the scope of improvement.
- To ensure QMS activity in SAP to maintain in the compliance status as per GMP.
- Perform Vendor Qualification as per standards to meet the GMP requirements.
- Collection, compilation and review of Vendor documents, Coordination with supplier / Manufacturer for Audit / documents, manage audit schedules.
- Annual Evaluation of Raw and packaging material vendors, coordination with plant team recommended action implementation.
- Inspection of Raw material and Packaging materials manufacturing facility, supplier's facility, monitoring the compliance, approval or disapproval of manufacturers and vendors.
- To establish, review and approve Quality Agreement with Vendor/Supplier.
- Prepare review and revise the SOPs as per changes in guideline within assigned period.
- Ensure on-time revision/ review of SOPs implementation and maintain the compliance.
- Ensure consensus of stakeholder on revised SOPS by taking feedback and conduct review meeting.
- Assessment of documentation generated at cross functional departments.
QA Executive
HARMAN FINOCHEM LIMITED
Aurangabad
03.2022 - 09.2024
- To compile and review the documents required for ANDA filing and variation filing of the product.
- To perform the assessment for the introduction of a new product at the site.
- Preparation and review of validation protocols (including processes and packing), reports, and other relevant documents in Caliber DMS.
- To prepare and review the study protocol for validation batches, including the alcohol dose dumping study, multimedia dissolution study, photo-stability study, freeze-thaw study, applesauce/chocolate pudding study, splitability study, etc.
- Preparation and review of the hold time study protocol and report in Caliber DMS.
- Monitoring and optimization of all process validation batches.
- To prepare and revise quality documentation, such as the site master file and the validation master plan.
- Commissioning and qualification of non-sterile oral solid dosage process equipment.
- To perform, review, and participate in Quality Risk Assessments and Gap Assessments.
- To prepare and review elemental and NDMA risk assessments of products.
- To conduct and participate in transport validation and supply chain assessment of the product.
- To review technology, transfer documentation, and its related documents.
- Document controls, including issuance, retrieval, storage, and destruction.
- To prepare and review the annual product quality review (APQR), and continuous process verification (CPV).
- To initiate and review the quality management system documents, such as change control, deviation, incident, corrective and preventive action, investigation, etc.
- To conduct and participate in self-inspection.
- Perform internal and external quality audits.
- Report on the outcome of inspections, ensure responses are compliant with regulatory requirements, and keep management informed.
- Report on product, process, and system risks.
- Host the audits from regulatory, customer, etc.
- Provide an appropriate response to the audit observation and the corrective and preventive action report to regulatory authorities, customers, etc.
- Review Quality/Technical Agreements.
- To prepare, review, and revise the standard operating procedure.
- To conduct the on-the-job training of new employees joining the QA department.
QA Executive
ALEMBIC PHARMACEUTICAL LIMITED
Vadodara
04.2019 - 02.2022
- Prepared process validation protocols and reports for compliance and efficiency.
- Conducted hold time study protocols and reports to ensure product integrity.
- Monitored process validation batches to maintain quality standards throughout production.
- Reviewed and compiled data for QMS documents, including change control and CAPA.
- Executed qualifications by reviewing URS, DQ, IQ, OQ, PQ, and CQ documents.
- Coordinated with third parties on qualification and validation activities.
- Planned requalification and revalidation activities according to VMP guidelines.
- Managed IPQA activities across all sections, ensuring adherence to standards.
QA Executive
TORRENT PHARMACEUTICAL LIMITED
Dahej
01.2017 - 04.2019
- Executed line clearance in manufacturing and packing areas to ensure operational efficiency.
- Ensured compliance with IPQA activities according to standard operating procedures and documented findings.
- Adhered to GMP, GDP, ALCOA+, and EHS procedures for quality assurance.
- Reviewed and verified all IPQA and production documents for accuracy and completeness.
- Withdrew in-process samples and recorded entries in respective documents.
- Reported non-conformance issues observed on the shop floor to senior management for prompt resolution.
- Conducted acceptance quality level (AQL) assessments to maintain product standards.
- Participated in process validation activities, withdrawing BU and stratified samples per approved protocol.
QA Officer
AUROCHEM PHARMACEUTICAL PVT LTD
Palghar
09.2015 - 01.2017
- Executed line clearance in manufacturing and packing areas to ensure process efficiency.
- Monitored in-process activities within manufacturing and packing to uphold quality standards.
- Issued batch manufacturing records (BMR), batch processing records (BPR), and protocols.
- Tracked stability and control samples for compliance with regulatory requirements.
- Affixed product release labels on containers to guarantee proper identification.
- Performed acceptance quality level (AQL) inspections to assess product quality.
- Reviewed batch-related documents, including BMR, BPR, and daily logbooks for accuracy.
- Maintained all IPQA-related documents during audits to support compliance efforts.
QA Chemist
HINDUSTAN LABORATORIES
Palghar
01.2015 - 08.2015
- Conducted cleanliness and environmental monitoring in manufacturing and packing areas before activities commenced.
- Performed in-process checks to ensure quality standards were met.
- Executed Acceptance Quality Limit (AQL) assessments for product compliance.
- Managed document control, overseeing issuance, retrieval, storage, and destruction processes.
- Conducted monthly GMP rounds on shop floor to verify compliance with observations.
- Checked Standard Operating Procedure (SOP) compliance on shop floor regularly.
- Reviewed Batch Manufacturing Records (BMR) and Batch Production Records (BPR) for accuracy.
Education
Master in Pharmacy - Quality Assurance
Aanasaheb Ramesh Ajmera College of Pharmacy
Dhule, Maharashtra01.2015
Bachelor of pharmacy -
Aanasaheb Ramesh Ajmera College of Pharmacy
Dhule, Maharashtra01.2013
HSC -
J.R. City College
Dhule, Maharashtra01.2009
SSC -
K.S.K. New City High School
Dhule, Maharashtra01.2007
Skills
- Quality management systems
- Regulatory compliance
- Auditing and assessment
- Vendor management
- Risk analysis
- Process validation
- Document control
- GMP training
- Project management
- Effective communication
- Problem solving
- Team collaboration
- Computer proficiency
Affiliations
- Participate in CSR activities carried out by the company.
- Involvement in organizational events or sports tournaments.
Accomplishments
- Appreciation award received for successfully carrying out two USFDA audits with zero 483 observations during my work with Harman Finochem
- Best Performance Award, Year 2023
Certification
- Approved pharmacist license received by the State FDA
Languages
Marathi
First Language
English
Proficient (C2)
C2
Hindi
Proficient (C2)
C2
Familiar Software
- Caliber DMS
- Caliber QMS
- Nichelon for Training management
- ATLTMS for Training management
- SAP (All Module)
- Tantrasoft
- Trackwise
- · LMS
Timeline
Senior Executive
BLISS GVS PHARMA LIMITED
09.2024 - Current
QA Executive
HARMAN FINOCHEM LIMITED
03.2022 - 09.2024
QA Executive
ALEMBIC PHARMACEUTICAL LIMITED
04.2019 - 02.2022
QA Executive
TORRENT PHARMACEUTICAL LIMITED
01.2017 - 04.2019
QA Officer
AUROCHEM PHARMACEUTICAL PVT LTD
09.2015 - 01.2017
QA Chemist
HINDUSTAN LABORATORIES
01.2015 - 08.2015
Master in Pharmacy - Quality Assurance
Aanasaheb Ramesh Ajmera College of Pharmacy
Bachelor of pharmacy -
Aanasaheb Ramesh Ajmera College of Pharmacy
HSC -
J.R. City College
SSC -
K.S.K. New City High School
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