Dhruv Sherdiwala
LONDON
Summary
Quality Assurance professional with strong background in ensuring product integrity and compliance. Known for fostering team collaboration and adapting to evolving project demands while consistently achieving high-quality results. Equipped with analytical skills, attention to detail, and commitment to continuous improvement.
Overview
10
10
years of professional experience
Work History
Quality Assurance Specialist
STEMCELL Technologies
04.2023 - 05.2024
- Used SAP ERP for review of QC testing, batch manufacturing records and release of product
- Review, verification, processing of QMS records to ensure compliance to Quality Management Standards such as ISO 9001, ISO 13485, relevant GMPs and established procedures. Product review includes- media products, instrumentation, CMO products and cell separation kits
- Review and approval of QC testing reports associated with batch release
- Utilized root cause analysis techniques to identify underlying issues contributing to product defects or customer complaints.
- Included coordination with other departments such as manufacturing, QC, supply chain and finished goods
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Mentored junior QA Associates, fostering a culture of continuous learning and professional growth.
- Performed risk assessments on potential new projects, helping management make informed decisions about project priorities.
- Improved product quality and customer satisfaction by identifying and resolving defects before market release.
- Collaborated with cross-functional teams to develop robust quality assurance strategies for new products.
- Enhanced team collaboration, leading cross-functional meetings to discuss quality assurance findings and improvements.
Quality Assurance Specialist (Promoted)
Catalent Pharma Solutions
10.2019 - 04.2023
- Trained QA Associates on: Audit of batch records (manufacturing & packaging), Interim release of bulk for final packaging (bottling/ blistering), Final release of commercial lots to Canadian and US markets, Packaging component AQL, sampling and inspection, Capsule print check qualification, Line clearance qualification (Cube Test)
- Initiate and manage deviations, Root Cause Analysis (critical & major), CAPA using TrackWise QMS Software
- Member of complaint investigation team: Provide quality inputs for complaint investigations
- Review analytical reports and initiate lab investigations for out-of-specification events
- Identify, improve, and monitor noncompliance
- Manage internal change control process through TrackWise
- Periodic review of SOPs & quality forms
- Leading Environmental Microbial Monitoring Program for Catalent Strathroy facility
- Weekly aseptic water sampling, ambient air/ compressed air sampling, swab sampling, contact plates etc.
- QA Liaison between manufacturing and launch excellence team to define and monitor critical quality attributes for the launch of lots of new products
- Identify critical quality attributes in introduction of packaging components
- Monitor GMP compliance on the shop floor & warehouse
- Address issues of noncompliance
- In-process and final release auditing confirming the batch was executed in compliance with cGMP and SOPs
- Lead retention and archival of Quality Documents such as BMR/BPR, logbooks, component masters, analytical reports, validation documents
- Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and QA management as required
- Line clearance and release of production and packaging areas including compounding, encapsulation, finishing, bottling, blistering and cartoning lines
- Compliance audits in all production departments and prepare results for product and QA management
- Encompasses in readiness activities related to internal, regulatory agencies and notified body inspect and conduct periodic Internal audit
- Address returned material authorization requests (RMAR), review and approval returned material/ product
- Enhanced customer satisfaction by addressing reported issues promptly and providing effective solutions.
- Achieved timely resolution of non-conformance issues by implementing corrective action plans working closely with relevant departments.
Quality Assurance Associate
Catalent Pharma Solutions
10.2019 - 10.2021
- In-process and final release auditing confirming the batch was executed in compliance with cGMP and SOPs
- Reporting non-conformances including manufacturing issues and deviations
- Relevant in-process quality checks to check compliance and effect on SISPQ of the product
- Investigation of deviation using root cause analysis tools and technical writing, CAPA implementation using TrackWise software
- Review and generate analytical report templates for packaging components in accordance with the specifications
- AQL and in-process AQL sampling and analysis
- Acts as QA representative on shift in decision-making and issue resolution, escalating serious issues to production management and QA management as required
- Line clearance and release of production and packaging areas including compounding, encapsulation, finishing, bottling, blistering and cartoning lines
- Compliance audits in all production departments and prepare results for product and QA management
- Follow up on outstanding corrective actions from the audits to ensure timely completion of the action
- Prepare and issue product assessment protocols and reprocessing directives
- Sampling and testing/ IR analysis of packaging components
- Filing, archiving and review of quality documents such as MBPRs, Logbooks, intercompany transportation logs etc
Quality Assurance Executive
Envision Scientific & Concept Medical Inc.
04.2015 - 06.2019
- Quality Representative in Regulatory Audits
- Complaint Investigator/ Evaluator & Maintenance of Complaint Files (With Reference to 21 CFR Part 820.198, Complaint Files)
- Deviation investigation Report Writing
- Member of IDE (Investigational Device Exemption) submission & Premarket Notification- 510(k) submission team
- Qualified Internal Auditor
- Execution of Product (PTCA Drug Coated Balloon-DCB, Drug Eluting Stent, Nano Carrier Eluting Stents, PTA DCB- Superficial Femoral Artery, Below the Knee) & Process Validation (Primary Packaging- Sterile barrier system, Sterilization- SAL 10-6 & others)
- Preparation, control & monitoring of internal & external quality requirements including Change Control, Deviation Management & Corrective- Preventive Action (CAPA)
- Disposal of on shelf expired/complaint products as per regulations
- Continuous Improvement of Quality Management System
- Pre & post execution of Validation Documents
- Handle regulatory & customer Audits, Self- Inspection & Internal Audit
- Maintenance of Batch Manufacturing & Processing Records
- Daily checks of Products before and after starting work, Line Clearance
Sales Representative
Ami Pharma Pvt. Ltd.
09.2014 - 03.2015
- Develop sales in assigned territory as defined by the company
Lecturer
C. K. Pithawalla Institute of Pharmaceutical Sciences & Research
01.2014 - 08.2014
- Teach academic programs to the Bachelor of Pharmacy students
Education
Master of Science - Pharmaceutical Sciences
University of Pune
India05-2013
Bachelor of Science - Pharmacy
North Maharashtra University
India05-2011
Skills
- Quality Management System (QMS)
- SAP ERP, TrackWise QMS
- Quality assurance
- Deviation, CAPA management
- ISO standards, cGMP compliance
- Quality improvements
- Risk management
- Operation Monitoring
- Problem-solving skills
- Decision-making
- Auditing techniques
- PowerPoint
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
Gujarati
Native or Bilingual
Timeline
Quality Assurance Specialist
STEMCELL Technologies
04.2023 - 05.2024
Quality Assurance Specialist (Promoted)
Catalent Pharma Solutions
10.2019 - 04.2023
Quality Assurance Associate
Catalent Pharma Solutions
10.2019 - 10.2021
Quality Assurance Executive
Envision Scientific & Concept Medical Inc.
04.2015 - 06.2019
Sales Representative
Ami Pharma Pvt. Ltd.
09.2014 - 03.2015
Lecturer
C. K. Pithawalla Institute of Pharmaceutical Sciences & Research
01.2014 - 08.2014
Master of Science - Pharmaceutical Sciences
University of Pune
Bachelor of Science - Pharmacy
North Maharashtra University
Similar Profiles
MUNMUN GREGERMUNMUN GREGER
Scientific Sales Representative at STEMCELL TechnologiesScientific Sales Representative at STEMCELL Technologies
Marcus CartagenaMarcus Cartagena
Building System Specialist at STEMCELL TechnologiesBuilding System Specialist at STEMCELL Technologies
Eithne McDonaghEithne McDonagh
Operations Associate at Stemcell TechnologiesOperations Associate at Stemcell Technologies