NIKUNJ PATEL
Richmond,TX
Summary
Dedicated Quality Assurance Manager with comprehensive expertise in all facets of QA operations, laboratory management, and adherence to policies and procedures. Proven track record in hiring and nurturing individual team members to cultivate a high-performing workforce. Committed to conducting meticulous assessments of product quality and manufacturing processes, driven by a robust engineering background. Recognized as a Certified FMEA specialist by AIGPE/CPD and LBMS Yellow Belt certified, with additional proficiency demonstrated through Lonza Qualified Train the Trainer program. Passionate about achieving excellence and ensuring customer satisfaction through stringent quality standards.
Overview
12
12
years of professional experience
Work History
QA Manager
Lonza Biologics Inc
08.2022 - Current
- Led and provided guidance to Quality Associates in executing batches and reviewing GMP documentation, ensuring compliance with regulatory standards and company policies
- Developed, directed, and maintained quality systems supporting CT manufacturing, incorporating audits, documentation management, and regulatory inspections
- Collaborated with site QA functions to establish and maintain interfaces with site-based QA systems, fostering effective communication and alignment
- Oversaw all aspects of QA front-facing operations within the cell therapy facility, including batch record review, on-floor QA support, MODA data review, and quality oversight for APSs
- Provide QA support for internal and external projects and team meetings, ensuring timely resolution of quality issues
- Build and maintain expertise within the QA Ops teams, including the development of staff through training and mentorship programs
- Apply aseptic manufacturing experience, including aseptic process validation, to ensure that CT operations meet customer and regulatory expectations for aseptic manufacturing throughout all phases of product development
Compliance QA Manager
Cambrex (CDMO)
08.2021 - 06.2022
- Root-Cause Investigations and CAPA Management; and Change Management activities
- Review and Approval of Specifications, Sampling Plans, Test Methods, Master Batch Records/Executed Batch Records, Analytical /Biological Test data Package for Manufacturing Disposition
- Monitoring Manufacturing Campaigns at Contract drug manufacturing Organizations (CDMO), Review and approval of Master Batch records, Specifications, Change Controls, Deviations and CAPAs
- Represent Quality as Quality lead in new Product Development Project (s) assigned and will play lead role in Quality Planning and support in defining Process Validation Strategy and discuss ongoing discussion of investigation and CAPA (Manage 10 + client)
- Provide site wise training for Track Wise software and ensure GDP training of all employees
- Reviews, maintains Quality metrics like change control, CAPA, Investigation, complaint investigation, stability, FAR tracking
- Participate in all regulatory, corporate and customer audits and inspections, and corrective action responses
- Manage implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support to meet product quality standards
- Oversee 'On Hold' product program, including status, release, and destruction of 'Rejected' products
- Provide Quality oversight and leadership within Operations & Manufacturing Support (Including Quality Control) departments in the execution of key quality systems, and ongoing Continuous process improvement
- Actively listened to customers' requests, confirming full understanding before addressing concerns Maintained energy and enthusiasm in fast-paced environment
- Worked flexible hours, night, weekend, and holiday shifts
Quality Assurance Supervisor
Amneal Pharmaceuticals
01.2020 - 08.2021
- Managing team of 12 QA inspector, 2 system coordinator, 4 quality auditor and 2 Investigation specialist
- Prepares, Reviews Annual Product Review (APR) for existing products/New Product
- Reviews, maintains Quality metrics like change control, CAPA, Investigation, complaint investigation, stability, FAR tracking Successfully handle Back office during FDA inspection (No FDA 483 in 2021)
- Writes, reviews, evaluates Deviations, Incidents, CAPAs, Complaints and Change Controls Schedule and coordinate daily priorities for raw material sampling, in-process material, finish product and in-process packaging/Labeling operation sampling and inspection activities
- Preparation, Management and follow ups of FDA responses
- Work with cross functional teams to perform RCA (5 Why, Fishbone Diagram), identify failure modes, and propose appropriate CAPA
- Create/ Maintain Quality manual for QA related function
- Participate in all regulatory, third party and customer audits and inspections, and corrective action response
- Make proactive recommendations and offering/presenting solutions to the Quality Systems & Regulatory Compliance Department Management to improve quality and work efficiency
- Reviews and approves Engineering Validation Protocols for Equipment's, Facility, Temperature Mapping and Purified Water system
- Performed Gap analysis of Quality Management System and lead team for closure of findings
- Assist management with development of new and revised SOP, execute validation and qualification study
- Experienced of working on different Quality software, Qumas, Master control, and caliber
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies
- Oversaw onboarding and training of new employees to promote qualified and well-coordinated quality assurance team
Quality Assurance Specialist III
Torrent Pharmaceuticals, Inc
11.2018 - 01.2020
- Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments
- Writes, reviews, evaluates Deviations, Incidents, CAPAs, Complaints and Change Controls
- Assist in the coordination of testing results involving finished products, raw materials, and packaging components and the appropriate release and hold programs associated with these materials Developed supply chain program for international shipments
- Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support to meet product quality standards
- Oversee the 'On Hold' product program, including the status, release, and destruction of 'Rejected' products
- Reviews and approves Engineering Validation Protocols for Equipment's, Facility, Temperature Mapping and Purified Water system
- Oversight and approval of SOPs and controlled documents
- Reviews, maintains, and provides Quality metrics monthly to management
Quality Assurance Specialist III
Amneal Pharmaceuticals
08.2015 - 11.2018
- Support plant/process deviation reports for new and existing products
- Collaborates significantly with cross functional groups, including Quality, Manufacturing, Process Development, and Facilities
- Reviewal of IQ/OQ/PQ protocols for studies of equipment/processes and implementing them Reviewal of cleaning validation protocol and execute them accordingly
- Assisted in creating a process for ANDA (Abbreviated New Drug Application) batches and initiate stability study for FDA filing
- Experience to handle FDA audit and help team to retrieval document during audit
- Create and maintain procedures for document workflow, document retention, archiving and retrieval
- Perform Environmental Studies for cGMP area and performed Visual inspection for product degradation after 1st year and at expiration Perform testing to meet acceptant quality limit (AQL) for finished product and documented in the Master batch record
- Perform transaction in JDE (Oracle) i.e inventory management system, to maintain production inventory
- Prepare, distribute, and archive documentation and information as necessary; manage structure and content in file management drive
Quality Assurance Associate
Valeant Pharmaceutical
11.2012 - 10.2014
- Track and trend relevant quality metrics including air sample, DI water sample, Swab sampling
- Perform Visual inspection on Package QA retain and assist in preparation of report for APR
- Assist QA manager for CAPA resolution and review of change Controls, SOPs, protocols/reports and quality indicator review
- Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements
- Perform Raw Material sampling, finish product bulk sampling and collect Package finish product for QC and QA retain
- Handling customer complaint, including logging complaints and performing and writing investigations
- Issuance of Labeling component as per production Request
Education
Post Graduate - Environmental Protection Technology
Centennial College
Toronto, ONBachelor of Engineering - Chemical
GCET College of Engineering And Technology
01.2008
Skills
- Staff training and development
- Knowledge of quality systems
- Pre-implementation audits
- Employee supervision
- Certified FMEA by AIGPE/CPD
- LBMS Yellow belt
- Quality Systems Development and Implementation
- Regulatory Compliance (US FDA, European Regulations)
- Batch Record Review and GMP Documentation
- Aseptic Manufacturing and Process Validation
- Cross-functional Collaboration
- Staff Development and Training
- Quality Oversight and Troubleshooting
Timeline
QA Manager
Lonza Biologics Inc
08.2022 - Current
Compliance QA Manager
Cambrex (CDMO)
08.2021 - 06.2022
Quality Assurance Supervisor
Amneal Pharmaceuticals
01.2020 - 08.2021
Quality Assurance Specialist III
Torrent Pharmaceuticals, Inc
11.2018 - 01.2020
Quality Assurance Specialist III
Amneal Pharmaceuticals
08.2015 - 11.2018
Quality Assurance Associate
Valeant Pharmaceutical
11.2012 - 10.2014
Bachelor of Engineering - Chemical
GCET College of Engineering And Technology
Post Graduate - Environmental Protection Technology
Centennial College
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