Head Of Quality And Regulatory
Current
Jan 2024 - Present
AeroLeads people directory · profile
Niraj Patel Email & Phone Number
Head of Quality and Regulatory Affairs
at
Aspire Pharmaceuticals
1 work email found
@cambrex.com
2 phones found area 201
LinkedIn matched
✓ Verified July 2026
4 data sources
Profile completeness 100%
Current company
Role
Head of Quality and Regulatory Affairs
Location
Somerset, New Jersey, United States
Who is Niraj Patel? Overview
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Quick answer
Niraj Patel is listed as Head of Quality and Regulatory Affairs at Aspire Pharmaceuticals, based in Somerset, New Jersey, United States. AeroLeads shows a work email signal at cambrex.com, phone signal with area code 201, and a matched LinkedIn profile for Niraj Patel.
Niraj Patel previously worked as Head of Quality and Regulatory at Aspire Pharmaceuticals and Site Head of Quality at Kashiv Biosciences Llc. Niraj Patel holds Master'S Degree In Pharmaceutical Manufacturing, Mechanical Engineering from Stevens Institute Of Technology.
Company email context
Email format at Aspire Pharmaceuticals
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{first}.{last}@cambrex.com
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Profile bio
About Niraj Patel
Experienced Quality Leader with a demonstrated history of working in the pharmaceuticals industry. Skilled in Good Laboratory Practice (GLP), Cleaning Validation, Research and Development (R&D), U.S. Food and Drug Administration (FDA), and Technology Transfer. Strong quality assurance/management and quality control professional with a Masters in Pharmaceutical Manufacturing and Business Administration (M.B.A.) focused on Comprehensive Management .
Listed skills include Gmp, Validation, Capa, Fda, and 22 others.
Current workplace
Niraj Patel's current company
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11 roles
Niraj Patel work experience
A career timeline built from the work history available for this profile.
Site Head Of Quality
Apr 2023 - Mar 2024
Site Head Of Quality And Analytical Services
May 2021 - Apr 2023
Director/Site Quality Head, Quality Management
Mar 2021 - May 2021
Associate Director/Site Quality Head, Quality Assurance
Mar 2019 - Mar 2021
Manager, Quality Assurance
Accomplishing quality assurance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, and disciplining employees; communicating job expectations; planning, monitoring, appraising, and reviewing job contributions; planning and reviewing compensation actions; enforcing policies and procedures.Achieving quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.Meeting quality assurance financial objectives by estimating requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions.Developing quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.Validating quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.Preparing quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.Responsible for review and approval of investigations, CAPA's, change controls and deviations.Responsible for maintaining, updating and tracking of quality metrics for weekly trend review and compliance meetings.
Mar 2015 - Mar 2019
Supervisor, Quality Assurance
Leading the GMP compliance efforts for pharmaceutical production process related to solids/ liquid/ ointments/ creams/ gel/ powder for solution/ suspension oral dosage forms.Monitoring and auditing manufacturing for cGMP compliance and serving as a key resource to production and laboratory activities regarding quality and compliance issues.Supervising the manufacturing floor activities and all GMP documentation with seven direct reports.Resourcefully participated in handling market customer complaints (Quality complaints as well as Adverse drug event complaints) by investigating the complaints and to rectify by identifying the root cause for the same.Enthusiastically assisted in the training of new and current employees in the manufacturing, formulation development department, and quality departments regarding cGMP and other quality related issues.Responsible for maintaining and improving product quality by completing internal product, company, system, compliance and surveillance audits, investigating customer complaints; collaborating with FR&D and engineering departments to develop new product and engineering designs and manufacturing and training methods. Review of equipment qualification documents, packaging / manufacturing batch records, process performance qualification protocols, cleaning validation / verification protocols, process study protocols, investigational product sampling protocols, blinding study protocols, stability protocols, reprocessing protocols, change controls, planned deviations and unplanned investigation reports.Responsible for performing vendor audits as well as audits at the CMO sites.
Jul 2012 - Mar 2015
Validation Specialist
Validation - Preparation of Process Validation Protocols for ANDA submission batches, validation and commercial batches. Coordinate activities with R&D and Operations departments for procurement of raw materials, material releases & documentation of project's progress. Performing Environmental Monitoring studies, which includes Microbiological Air Sampling and Equipment Rinse and Swab Sampling.Preparation of Cleaning Verification & Validation Protocols for new products analyzing the product contact areas and the designing cleaning methods to be used for various equipments.Accomplishment - Successfully executed Validation program for more than 14 commercial and 24 ANDA filings.
Mar 2011 - Jul 2012
Qa Specialist / Stability Co-Ordinator
Multitasking Position reporting directly to Sr. Director, Quality Management. QA Coordination - Review process change requests, planned deviations and interface with R&D and Manufacturing departments regarding change requests & customer complaints, Prepare Annual Product Reviews, Review and revision of Quality Department SOP's, Batch Record Issuance & review, Label control. Assisted in the training of new and current employees in the manufacturing, Formulation development department, and quality departments regarding cGMP and other quality related issues.Stability Co-ordination -Responsibilities included Daily oversight and maintenance of stability program in accordance with ICH and FDA stability guidelines and requirements, Generating stability protocols, interpreting results, and writing interim and final stability reports. Monitoring, maintaining and qualifying stability environmental chambers. Experience with LIMS for Stability Coordination with the Laboratory.Accomplishment - Implemented systematic Stability Scheduling and enhanced the stability sample program.Accomplishment - Streamlined the Change Control System and created new SOP's for QA. Prepared investigation reports for process deviations, failures, complaints, and CAPA's.Working under strict cGMP environment, Responsibilities include supervision of line clearances for Production and Packaging line, Perform raw material sampling, in process checks, finished product sampling from Blends, compression, Coating, as well as liquid manufacturing. Overall Monitoring of Water System
Mar 2011 - Jul 2012
Sr. Quality Specialist
Briyosis Soft Gels Private Ltd
Jan 2007 - Dec 2008
Training In Qa And Qc Department
Moxy Laboratories
Performed water content of the finished products using the Karl fischer titration.Performed HPLC, UV spectroscopy, and titrimetry in accordance with the SOPs
May 2006 - Jul 2006
3 education records
Niraj Patel education
Master'S Degree In Pharmaceutical Manufacturing, Mechanical Engineering
Stevens Institute Of Technology
Master Of Business Administration (M.B.A.), Comprehensive Management
Goldey-Beacom College
Bachelor Of Pharmacy (B, Pharm
Rajiv Gandhi University Of Health Sciences
FAQ
Frequently asked questions about Niraj Patel
Quick answers generated from the profile data available on this page.
What company does Niraj Patel work for?
Niraj Patel works for Aspire Pharmaceuticals.
What is Niraj Patel's role at Aspire Pharmaceuticals?
Niraj Patel is listed as Head of Quality and Regulatory Affairs at Aspire Pharmaceuticals.
What is Niraj Patel's email address?
AeroLeads has found 1 work email signal at @cambrex.com for Niraj Patel at Aspire Pharmaceuticals.
What is Niraj Patel's phone number?
AeroLeads has found 2 phone signal(s) with area code 201 for Niraj Patel at Aspire Pharmaceuticals.
Where is Niraj Patel based?
Niraj Patel is based in Somerset, New Jersey, United States while working with Aspire Pharmaceuticals.
What companies has Niraj Patel worked for?
Niraj Patel has worked for Aspire Pharmaceuticals, Kashiv Biosciences Llc, Cambrex, Amneal Pharmaceuticals, and Briyosis Soft Gels Private Ltd.
How can I contact Niraj Patel?
You can use AeroLeads to view verified contact signals for Niraj Patel at Aspire Pharmaceuticals, including work email, phone, and LinkedIn data when available.
What schools did Niraj Patel attend?
Niraj Patel holds Master'S Degree In Pharmaceutical Manufacturing, Mechanical Engineering from Stevens Institute Of Technology.
What skills is Niraj Patel known for?
Niraj Patel is listed with skills including Gmp, Validation, Capa, Fda, Sop, V&V, Hplc, and Quality Control.
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