Kapil Neyyala
Quality Assurance
Hyderabad,Telagana
Overview
17
17
years of professional experience
Work History
QA Manager
Hetero Labs limited
08.2022 - Current
- Spearheading & supervising the Qualification Team and one Cluster activities in Quality Assurance Department
- Following & providing guidance to the team on respective departmental activities and the roles
- Expertise in handing of quality systems such as change controls, deviations, OOS, OOT, APQR, Audit Compliance, Validations (Process & Cleaning), IPQA activities, product release, preventive maintenance & calibration programme
- Lead the deviation investigation activities, conducting root cause analysis, writing comprehensive investigation reports, and tracking Corrective and Preventive Actions (CAPA) to ensure timely resolution and continuous improvement
- Handling of Customer audits, and internal audits on monthly basis across Units
- Played a vital role towards successful implementation of CAPS, QMS (Change management, CAPA, Deviation & Investigation tool), WMPS and LMS (training tool)
- Being a Qualified trainer providing the trainings to the employees on cGMP, and OJT as per defined Annual Schedule/s
- Played a vital role towards successful implementation of few Standard Operating Procedures
- Review & verification of batch production records, raw data, Reports, Records, Prints, Log books and all other cGMP records
- Coordinate with engineering, warehouse, QC, and production to establish corrective actions regarding quality related issues
- Review of Annual Product Review and process capability index (Cpk)
- Responsible for supplier qualification for Excipients, packing materials, KSM, GRM
- Performing on-site audits of suppliers and risk assessments at various stages of suppliers, negotiating and approving quality agreements with suppliers.
QA Team Leader
Aurobindo Pharma limited
09.2016 - 09.2022
- Handle the Change control, Qualification and vendor team as a team leader and following and providing guidance to the team, vendor documents review effectively through Oracle Agile PLM QMS software system
- Review of N-Nitrosamine impurities (NDMA & NDEA) Risk assessment protocols & reports for various API products
- Review of Elemental impurities Risk assessment protocols & reports for various API products as per ICH Q3D & ICH Q9
- Review of MPCRs & BPCRs, Quality Reports, Qualification Reports and Specification & STP's
- Review of Master production & control records (MPCR), and Batch production & control records (BPCR) through Tech pack
- Actively participate in USFDA WL response and ensuring the implementation/Effectiveness of the CAPA
- Handling of deviations, change controls, OOS, OOT through Agile PLM QMS software system and coordination in investigations for the Identification of root cause & review of implementation/Effectiveness of CAPA
- Preparation and Review of Annual Product Review and process capability index (Cpk).
Executive in Quality Assurance
Hikal limited
01.2014 - 09.2016
- Coordination in review and investigation of customer complaints, Preparation of Audit Reports, Root cause analysis and implementation of CAPA and reviewing for its effectiveness
- Responsible for quality assurance activities, Line clearance for manufacturing and packing operations, sampling at different stages of manufacturing Qualification (IQ, OQ & PQ) of new equipment including re-qualification of existing equipment and AHUs Handling in various Investigations for Deviations and out-OfSpecifications for the identification of root cause and implementation of corrective and preventive actions and reviewing for its effectiveness
Executive in Documentation & GMP Team
Biocon limited
09.2009 - 12.2013
- Active Role in Regulatory authorities inspections such as USFDA, WHO, EDQM, MHRA, PMDA, ANVISA, Health Canada, and more
- Actively participate in USFDA WL response and ensure CAPA implementation/effectiveness
- Part of teams serving major customers like Pfizer, Merck, Abott, Teva, Sanofi, Glenmark, Actavis, Johnson & Johnson, & GSK
- Strong exposure in Qualifications, Change Controls, Validations, Vendor Qualification Activities and Conducting Internal Compliance
- Comprehensive experience in documentation as per Regulatory norms and Quality systems
- Handling of deviations, OOS, OOT through Agile PLM QMS software, including root cause identification and CAPA review
- Handling of Technology Transfer activities
- Skills in Validations, Audits & Compliance, Customer & Regulatory audits, and Vendor Management in Pharma
- Performing Internal audits as per schedule
- Preparation and Review of Annual Product Review and process capability index (Cpk)
- Preparation of reports for Monthly Quality review meetings and Management review meetings
- Providing cGMP training program to all employees
- Responsible for supplier qualification, onsite audits, and approving Quality Agreements
- Review of Elemental impurities Risk assessment protocols & reports for various API products as per ICH Q3D & ICH Q9
- Review of MPCRs & BPCRs, Quality Reports, Qualification Reports, and Specification & STP's
- Review of N-Nitrosamine impurities (NDMA & NDEA) Risk assessment protocols & reports for various API products
- Review of vendor qualification and evaluation
- Reviewing CQA, CQC, and API Site SOPs.
Executive in Pilot Plant
MSN Labs limited
10.2007 - 09.2009
- Supporting during Execution of trial and validation batches in Pilot plant for new projects
- Raw-material charging into vessels & reactors
- Maintaining good Housekeeping in pilot plant including
- Maintenance of clean rooms under controlled temperature and Humidity
- Updating log books and calibration of instruments
- Prepare and maintain standard operating procedures (SOPs) and other quality documentation
- Ensure adherence to quality management systems (QMS), Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP)
- To maintain accurate and reliable records including batch records and relevant documentation
- Comprehensive experience in GMP Documentation & Audit Preparedness as per Regulatory norms and Quality systems.
Education
M.Sc in Chemistry -
Nagarjuna University
08.2022
B.Sc -
Andhra University
Intermediate (M.P.C) -
Board of Intermediate, Andhra Pradesh
Skills
- Qualifications
- Change Controls
- Validations
- Vendor Qualification Activities
- Audits & Compliance
- Customer & Regulatory Audits
- Regulatory Inspections (USFDA, WHO, EDQM, MHRA, etc)
- Risk Assessment on Nitrosamine & Elemental impurities
- CAPA Implementation and Effectiveness
- Deviations
- OOS and OOT Management
- Annual Product Quality Review(APQR)
- AGILE
- ERP System
- CAPS(Calibration and preventive maintenance system)
- QMS(Quality Management System)
- LMS (Learning Management system)
- WMPS
- MS - Office
- Communication
- Leadership
- Team Collaboration
- Problem-Solving
- Time Management
- Adaptability
- Attention to Detail
- Critical Thinking
Accomplishments
- Active Role in Regulatory authorities inspections such as USFDA, WHO, EDQM, MHRA, PMDA, ANVISA, Health Canada, and more.
- Actively participate in USFDA WL response and ensure CAPA implementation/effectiveness.
- Part of teams serving major customers like Pfizer, Merck, Abott, Teva, Sanofi, Glenmark, Actavis, Johnson & Johnson, & GSK.
- Strong exposure in Qualifications, Change Controls, Validations, Vendor Qualification Activities and Conducting Internal Compliance.
- Comprehensive experience in documentation as per Regulatory norms and Quality systems.
- Handling of deviations, OOS, OOT through Agile PLM QMS software, including root cause identification and CAPA review.
- Handling of Technology Transfer activities.
- Skills in Validations, Audits & Compliance, Customer & Regulatory audits, and Vendor Management in Pharma.
- Performing Internal audits as per schedule.
- Preparation and Review of Annual Product Review and process capability index (Cpk).
- Preparation of reports for Monthly Quality review meetings and Management review meetings.
- Providing cGMP training program to all employees.
- Responsible for supplier qualification, onsite audits, and approving Quality Agreements.
- Review of Elemental impurities Risk assessment protocols & reports for various API products as per ICH Q3D & ICH Q9.
- Review of MPCRs & BPCRs, Quality Reports, Qualification Reports, and Specification & STP's.
- Review of N-Nitrosamine impurities (NDMA & NDEA) Risk assessment protocols & reports for various API products.
- Review of vendor qualification and evaluation.
- Reviewing CQA, CQC, and API Site SOPs.
Pages
- 01, K a p i l N e y y a l a Q A M a n a g e r I am a self-motivated and active individual with a postgraduate degree in M.Sc. chemistry and over 16 years of experience in Pharmaceutical Quality Assurance departments at prestigious organisations. Audit and compliance, quality management systems, investigations, risk management, trainings, qualifications, and validations are among my areas of expertise. I have extensive experience building and maintaining quality management systems, as well as assuring regulatory compliance. I am well-versed in GMP rules and possess problem-solving abilities.
- 02, Active Role in Regulatory authorities inspections such as USFDA, WHO, EDQM, MHRA, PMDA, ANVISA, Health Canada, and more. Actively participate in USFDA WL response and ensure CAPA implementation /effectiveness. Part of teams serving major customers like Pfizer, Merck, Abott, Teva, Sanofi, Glenmark, Actavis, Johnson & Johnson, & GSK. Strong exposure in Qualifications, Change Controls, Validations, Vendor Qualification Activities and Conducting Internal Compliance. Comprehensive experience in documentation as per Regulatory norms and Quality systems. Handling of deviations, OOS, OOT through Agile PLM QMS software, including root cause identification and CAPA review. Handling of Technology Transfer activities. Skills in Validations, Audits & Compliance, Customer & Regulatory audits, and Vendor Management in Pharma. Performing Internal audits as per schedule. Preparation and Review of Annual Product Review and process capability index (Cpk). Preparation of reports for Monthly Quality review meetings and Management review meetings. Providing cGMP training program to all employees. Responsible for supplier qualification, onsite audits, and approving Quality Agreements. Review of Elemental impurities Risk assessment protocols & reports for various API products as per ICH Q3D & ICH Q9. Review of MPCRs & BPCRs, Quality Reports, Qualification Reports, and Specification & STP's. Review of N-Nitrosamine impurities (NDMA & NDEA) Risk assessment protocols & reports for various API products. Review of vendor qualification and evaluation. Reviewing CQA, CQC, and API Site SOPs.
Timeline
QA Manager
Hetero Labs limited
08.2022 - Current
QA Team Leader
Aurobindo Pharma limited
09.2016 - 09.2022
Executive in Quality Assurance
Hikal limited
01.2014 - 09.2016
Executive in Documentation & GMP Team
Biocon limited
09.2009 - 12.2013
Executive in Pilot Plant
MSN Labs limited
10.2007 - 09.2009
M.Sc in Chemistry -
Nagarjuna University
B.Sc -
Andhra University
Intermediate (M.P.C) -
Board of Intermediate, Andhra Pradesh
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