MINITAB-16
Ajaykumar Kukadiya
Pharmaceuticals Quality Assurance
Summary
Professional with over 12.5 years of QA experience in the pharmaceutical injectable facility. Having responsibility for plant quality system. Problem solver, decision maker, detail oriented & dedication to quality. Have worked in a consent decree environment and fully understand the importance of quality systems. Skilled professional focused on achieving success & management of quality.
Overview
13
13
years of professional experience
13
13
years of post-secondary education
3
3
Languages
Work History
Assistant Manager – Quality Assurance.
Intas Pharmaceutical (BioPharma)
06.2024 - Current
- Facilitated clear communication between Cross functional team member and upper management through regular meetings and updates of Annual product quality review (APQR) outcome.
- Established & maintained Annual product quality review (APQR) schedules and monitored product performance.
- Analyzed Deviation and Market complaint data to identify trends and provide recommendation accordingly.
- Expertise in integrating & implementing Quality management systems (QMS) to efficiently Initiate & review of change controls, Deviations, Corrective and preventive actions (CAPAs), Effectiveness check (ERs), and Investigations.
- Ensuring prompt resolution of any compliance concerns or audit findings and Proactively GAP Assessment.
Quality Assurance Senior Executive
SUN PHARMAEUTICAL INDUSTRIES LTD
10.2017 - 06.2024
- Effectively managing Change controls, Deviations, CAPA & Effectiveness check as a reviewer and a initiator in TrackWise ensures prompt resolution, compliance, and continuous improvement, driving enhanced quality and operational success.
- Influenced change management activities related to process enhancements, ensuring smooth transitions across all departments.
- Effective preparation and review of GMP documents, including Master Batch Manufacturing Records (MBMR), Standard Operating Procedures (SOPs) in EDMS, Elemental Risk Assessments, and study protocols, ensure regulatory compliance, quality assurance, risk management, continuous improvement, and operational efficiency.
- Prepare, execute, and report smoke studies to ensure compliance, enhance quality assurance, and drive operational improvement.
- To Plan & monitor Aseptic Process Simulation, Process validation & hold time study
- Trend, compile, and review quarterly and yearly internal quality observations, BMR reviews, Continuous process verification( CPV), Critical alarm, and intervention trends for operational improvement.
- Leverage expertise in SAP transactions to execute batch release, Bill of material approvals, Stock adjustment, and transaction confirmations, optimizing operational efficiency.
- Perform line clearance & oversight for injectable manufacturing (ampoules, vials, pre-filled syringes, cartridges, sterile API) ensuring CGMP compliance, product safety, and quality.
- Review executed BMRs, Audit trails, logbooks, protocols, and provide constructive feedback, ensuring compliance and enhancing operational accuracy and efficiency.
- Prepare and update the CPV (Continual Process Verification) protocol, ensuring compliance, accuracy, and alignment with regulatory standards for continuous improvement.
- Perform AQL (Acceptable Quality Limit) and visual inspection statistical sorting to ensure product quality, compliance, and operational efficiency.
- Trained new hires on best practices in quality assurance for Review, Finished product sampling, Line clearance ,fostering a high-performance work environment.
Quality Assurance Executive
GUFIC LIFESCIENCE PVT. LTD
09.2015 - 10.2017
- As In-process quality assurance (IPQA) Principal Team Lead responsible for providing quality support and direction to Manufacturing, Quality Control, and support functions.
- To ensure continued compliance to CGMPs as well as being responsible for providing leadership to the GBSL & GLPL IPQA team by assigning day to day tasks and ensuring completion.
- As IPQA Team Lead, represent IPQA Operations, fostering cross-functional collaboration to enhance quality, compliance, and efficiency.
- Actively participate in audits/inspections, addressing IPQA questions to ensure compliance and continuous improvement.
- Monitor production activities for injectable manufacturing (ampoules, vials, lyophilized vials) ensuring CGMP compliance, safety, quality, and continuous operational improvement.
- Ensure proper sampling of in-process, finished goods, control, stability, and validation samples, ensuring compliance and process integrity.
- Review executed BMR/BPR and QC data before batch release, ensuring accuracy, compliance, and efficient system integration.
- Maintained up-to-date knowledge of industry trends and best practices in order to drive innovation within the QA department.
- Conducted regular audits of manufacturing processes, ensuring compliance with industry regulations and company policies.
- Trained employees in best practices for quality assurance, fostering a culture of continuous improvement throughout the organization.
- To train new employee for IPQA activity
- Participate in QMS activities, including change control, deviation, and incident, ensuring continuous compliance and improvement.
QA EXECUTIVE
UNIQUE PHARMACEUTICAL LABORATORIES (JBCPL)
07.2013 - 09.2015
- In-Process Quality Assurance (IPQA) and line clearance for dispensing, manufacturing, filling, sterilization, packaging, and packaging material processing activities for large volume parenterals (LVP) and small volume parenterals (SVP) like ampoules and vials, ensuring compliance.
- Issuance of Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and monthly reports in compliance with regulatory standards to ensure accurate documentation and smooth production processes.
- Participate in re-qualification activities including media-fill, process validation, hold time studies, cleaning validation, autoclave, sterilizer, and CIP-SIP to ensure compliance, product safety, and operational efficiency.
- Review executed BMR, BPR, and QC data prior to final release, ensuring compliance
QA OFFICER
SOVEREIGN PHARMA PVT.LTD
05.2012 - 07.2013
- Execute IPQA during manufacturing and packing stages, ensuring clearance at each step, including dispensing, filtration, and packing, while enhancing compliance, product quality, operational efficiency, and continuous improvement in pharmaceutical processes.
- Review executed BMR and Packing Records for batch release, ensuring compliance, accuracy, and continuous quality improvement.
- Manage the storage, retrieval, and destruction of Master Batch Records,Specifications, Art works, Shade cards within the Master Document Management system, ensuring compliance, data integrity, and regulatory adherence throughout the process.
- Execute media fill activities to validate aseptic processing, ensuring compliance with regulatory standards, product safety, and quality assurance throughout the manufacturing process.
Education
Master of Pharmacy - Quality Assurance
SURESH GYAN VIHAR UNIVERSITY
04.2010 - 01.2012
Bachelor of Pharmacy -
SET'S COLLEGE OF PHARMACY
DHARWAD, KARNATAKA 04.2001 - 01.2009
High School Diploma -
M. N. J PATEL HIGH SCHOOL
SURAT, GUJARAT 04.2001 - 01.2005
Skills
Team leadership
undefinedPersonal Information
- Father's Name: Dhirubhai Kukadiya
- Date of Birth: 07/11/87
- Marital Status: Married
Awards
Sun Star Spot Award, 2019, Sun Pharma Ind. Pvt. Ltd
Software
SAP S/4 HANA
TRACKWISE
LMS-Sumtotal & Q-Edge LMS
Amplelogic
EDMS & Q-Edge DC
Q-Edge QMS
Expertise
- Extensive experience of Small volume parenteral with liquid and lyophilized Vials, Liquid Ampoules, Pre-filled syringes (PFS), Sterile eye drops, Cartridges, Dry Powder, sterile API processing, and Large Volume Parenteral (LVP).
- Exposure of Bio pharmaceuticals for Drug substances and drug products and Pharmaceuticals dosage forms.
- In-depth knowledge of aseptic processing and Quality management systems (QMS) for parenteral products and regulatory compliance.
- Exposure of various regulatory audits and compliant facilities like USFDA, MHRA, TGA, ANVISA, EU-GMP, MCC, Health Canada, and WHO-GMP.
Timeline
Assistant Manager – Quality Assurance.
Intas Pharmaceutical (BioPharma)
06.2024 - Current
Quality Assurance Senior Executive
SUN PHARMAEUTICAL INDUSTRIES LTD
10.2017 - 06.2024
Quality Assurance Executive
GUFIC LIFESCIENCE PVT. LTD
09.2015 - 10.2017
QA EXECUTIVE
UNIQUE PHARMACEUTICAL LABORATORIES (JBCPL)
07.2013 - 09.2015
QA OFFICER
SOVEREIGN PHARMA PVT.LTD
05.2012 - 07.2013
Master of Pharmacy - Quality Assurance
SURESH GYAN VIHAR UNIVERSITY
04.2010 - 01.2012
Bachelor of Pharmacy -
SET'S COLLEGE OF PHARMACY
04.2001 - 01.2009
High School Diploma -
M. N. J PATEL HIGH SCHOOL
04.2001 - 01.2005
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