SR. Quality Manager

Kanan Desai

Parsippany, NJ/ Email: ******@*****.*** /Cell: 551-***-****/ Linked In: linkedin.com/in/kanan-d-840b48139

SUMMARY

Result oriented strategic Quality Leader, having 15+ years of experience in the pharmaceutical, nutraceutical, cosmetic industry; result oriented, self motivated and achievement driven; Strong communication and problem-solving skills; interested in working for organization with challenging and creative environment to contribute in Quality to lead the company to the next level. Committed to continuous improvement and team development.

WORK EXPERIENCE

Innovation Labs, Mahwah NJ, Cosmetic, Personal Care and Dietary Supplement Industry Sr. Quality Manager/Director June 2020 – Present

1.Managing Direct reports and their responsibilities from Bulk QC, FG QC, Component QC, Raw Materials QC, Validation and QA. Provide Guidance for the execution of the task for each group.

2.Manage FDA, Audits, Customer Audits, Internal Audits and External Audits and audit response.

3.Managed closures of FDA 483 observations.

4.Product Registration with FDA, Facility Registration with FDA, NJ DOH, TGA, Health Canada, ISO 22716, etc.

5.Manage client facing conversations discussing and resolving product quality related issues or requests.

6.Oversee Quality Management system as whole. Conduct Annual cGMP trainings company wide.

7.Training direct reports their job functions and guide them for continuous improvement. Managing workflow and priorities.

8.Prepare Quality Monthly Reviews and KPIs. Track KPIs on a month for continuous improvement.

9.Constant troubleshooting the issues for Bulk, FG, Raw Materials, FG, Component, QA. Constant Troubleshooting of issue/nonconformances from Production, Manufacturing, Raw materials, QA, etc.

10.Method Development and setting up the Analytical lab /QC Bulk testing Lab including instruments such as Moisture Analyzer, HPLC, TOC Analyzer, etc.

11.Drafting, reviewing and approving SOPs, NCRS, Protocols, new forms, complaints, CAPAs, change controls, rework protocols. Manage Daily incident reporting in the elements.

12.Built the team from 5 to 30 employees and trained them and oversee a team of 30 employees. And manage over 10 direct reports.

13.Managing Temperature Humidity Monitoring Program for 1111 MacArthur Blvd and Sheffield location in Englewood and 300 Corporate Drive Mahwah Location.

14.Review of Validation protocols, review and approve FG and Bulk CoAs. Implementing new processes/SOPs.

15.Analytical lab (TOC, HPLC, any new machines, implementation of logbooks, IQOQs, Setting SOPs, Evaluating results)

16.Managing inventories for Quality Department (Bulk, FG, RM, Component, Analytical, QA, Validation).

17.Provide support to other departments (Accounting, Sales, Operations, Supply Chain, Process Engineering Purchasing, Planning, R&D).

18.Partnering with IT group for system compliance functions. Preparing Risk Assessments, Implemented training Matrix.

19.Partnering with Packaging R&D and Formulation R&D to prepare and assess bridging/leveraging statements of packaging and formulations.

Leading Pharma, Fairfield NJ, Pharmaceuticals

QA Manager May 2019 – June 2020

Managing Change controls, Deviations, issuing and reviewing batch records and releasing batches, Reviewing CMO batch documents/records and releasing CMO batches.

SOPs, Internal Audits, ensure compliance to cGMP and SOPs. Managing training program.

Work on Continuous improvement in process. Independently conduct investigations for manufacturing and

packaging operations.

Conduct Annual Product Reviews independently, Co-ordinate with Regulatory affairs/supply chain

department regarding change control approvals. Review Process validations, Cleaning validation and

equipment qualification protocols.

Englewood Lab, Englewood NJ, Cosmetic/Personal Care Industry

QA Compliance Manager Sept 2017 – Mar 2019

Manage Roles and Responsibilities of Direct Reports

Author, revise, review and approve SOPs

Author, review, manage and approve Process/cleaning validation protocols and reports. Manage OTC stability program.

Manage environmental monitoring and pest control program for the facility

Perform/manage annual drug reviews of OTC products

Conduct internal audits and mock recall.

Performed KPIs on Customer releases, rejections, deviations, change controls, product complaints, etc.

Process Change controls and Review batch records

Initiate, conduct, write and review Investigations (Nonconformances, QIRs, Deviations, SCARs and Product Complaints, trend investigations) for lotions, creams, ointments and semi solid products.

Host and support Customer Audits and Regulatory Audits.

Write Audit responses in a timely manner and Ensure closure of the CAPAs listed in the Audit response and collect documented evidences for those CAPAs.

Training Employees on SOPS, Protocols, CAPAs, Investigations and ensuring compliance to SOPs.

Interactions with Customer on day to day basis regarding any Quality related issues.

Preparing Training sessions and graphical presentation for employees to understand the process.

Manage closure of FDA 483 observation.

Carecam International Inc, Fairfield NJ, Pharmaceutical Industry

Quality Assurance Manager July 2017 – Sept 2017

Manage QA associates and other employees. Handling of customer complaints and write investigation reports for them.

Write and revise SOPs, train employees of SOPs and responsible for implementing SOPs.

Write CAPAs, Failure investigation, Deviation reports. Write Audit responses and Conduct internal Audits.

Handling of Customer and FDA audits.

NutriSport Pharmacal Inc, Franklin NJ, Nutritional Industry

QA/RA Specialist and Lab Manager Sept 2023 – July 2017

Reviewing batch manufacturing records and analytical data. Reviewing and releasing master batch manufacturing templates.

Approving CoAs’ of finished products and raw materials and releasing them

Conducting release and rejection of product and raw material batches, writing rejection notices for raw

material

Conducting lab investigations, OOS/OOT results investigations and preparing reports.

Writing SOPs for analytical lab, manufacturing and packaging and conducting training for SOP revisions.

Compliance deviation investigations and writing deviation reports and CAPAs .

Performing In-line packaging and tabletting checks, Participating in Mock recall and actual recall procedures

Collecting and reviewing source certificates and allergen statements of raw materials from vendors

Participation in conducting internal audits and FDA inspections and writing audit report

Participation in outside customer Audit support and writing audit report response

Managing current master product label logbook and obsolete label logbook

Reviewing and approving Raw material specification criteria, maintaining Reference material library for FTIR

Writing and approving Stability protocols and reports, Reviewing product labels and approving them

Maintaining Pest control, instrument calibration and weekly sanitation log, Manage laboratory inventory

Conducted HPLC operations, HPLC troubleshooting and expertise using Agilent Chemstation Software

Hands on Experience working with Agilent ICP-MS, Agilent GC, Troubleshooting on ICP-MS,And GC

Performed Raw Material testings doing wet chemistry and FTIR Identification.

Tests performed using pH meter, Karl Fischer, Distek dissolution, UV/VIS

Developed crucial analytical HPLC methods for complex products

Performed assays of stability batches and R&D batches, Managed lab chemicals, reagents and standard inventory

Followed cGMP, Good Documentation Practice (GDP), Good Laboratory Practice (GLP), other lab safety and personnel protection as per FDA and ICH Guidelines

Analyzed and reviewed chromatographic and QC test data, lab notebooks and prepared reports

Performed In Process, Finished Product, Stability, Raw Material Qualification testing, R&D Batch and In-house Std testing

Developed and created methods and maintained the inventory of current methods/SOPs and obsolete methods/SOPs

Maintained Temperature Log book for Standard Storage and Maintained all Lab instrument log books

QA/QC Chemist, Pharbest Pharmaceuticals, Farmingdale NY, Pharmaceuticals May 2010 – Sept 2012

Expertise in Dissolution testing including media preparation and Dissolution Calibration

Expertise in HPLC operation and calibration, Mobile Phase Preparation, HPLC troubleshooting and using HPLC EZChrome Software

Expertise in Atomic Absorption Spectroscopy(AA) operation, FTIR operation, UV/VIS spectrometer and Karl Fischer

Conducted calibration of UV/VIS and FTIR

Performed HPLC Method development and Validation (Linearity, Recovery) for in-process, finished and process validation

Followed cGMP, Good Documentation Practice(GDP), Good Laboratory Practice(GLP), other lab safety and personnel protection as per FDA and ICH Guidelines

Performed Cleaning Validation Method Development by HPLC (Linearity, Swab recovery, detergent bias, swab bias, detergent determination)

Analyzed and reviewed chromatographic and QC test data, lab notebooks and prepared reports

Managed QC lab chemical and reagents inventory and performed laboratory investigations for OOS/OOT results

Teaching Assistant, Stevens Institute of Technology, Hoboken NJ Jan 2009 – Dec 2009

Lab Associate, SIDMAK Laboratories Ltd, India Jan 2007 –Dec 2007 Intern, ALKEM pharmaceuticals Ltd, India Oct 2006 – Dec 2006

EDUCATION

Stevens Institute of Technology, Hoboken, NJ Dec 2009 Master of Science in Pharmaceutical Manufacturing GPA- 3.9

M.G.V’s Pharmacy College, Nasik, India July 2007

Bachelor of Pharmacy GPA- 3.7

SKILLS

Strong Communication, Technical writing

Strong presentation

Strong Computer, excel, word, adobe, Power point,

Smart draw software, Minitab software

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