Hi, I’m
Khushbu Patel
Old Bridge,NJ
Summary
Dedicated quality assurance professional with extensive experience in pharmaceutical and chemical industries, specializing in cGMP and FDA compliance. Proficient in analytical testing, quality control, and regulatory support, with a strong track record in managing investigations and ensuring product quality. Adept at utilizing advanced instrumentation and software to drive quality improvements and support organizational success.
Overview
11
years of professional experience
Work History
Glenmark Pharmaceuticals Inc.
QA Associate
05.2023 - Current
Job overview
- CMO activities includes, Preparing and maintaining quality agreements with more than 20 CMO and vendors.
- Reviewing and approving CMO SAFs & QMS documents like deviations, investigations, change control
- Handling of around 10 product quality complaints for CMOs and reporting of monthly quality report to I & C team
- Supporting QMS activities includes: Initiation, review, support for investigations, CAPA & change controls
- Support regulatory inspections (FDA, DEA, VAWD,/NABP, NJDOH), Provide support for consumer follow up for products.
- By providing online training to employees on Aspire, saving 20% of time in paper work and documentation.
Pfizer Inc.
QC Chemist
04.2022 - 11.2022
Job overview
- In role, I have executed Impurity testing through degradation and TLC, Assay on HPLC, and dissolution for Solid Dosage (Tablets, Capsules), Karl Fischer, and density. Adhering to stringent cGMP practices.
- Meticulously documented and maintained logbooks for all processes. possess extensive expertise in chromatography analysis, conducting thorough system suitability checks and evaluating test results against prior month stability results to ensure compliance with limit criteria.
- Additionally, adeptly handled investigations of laboratory incidents and out-of-specification or out-of-trend results. Throughout, have maintained open communication with my supervisor, providing regular updates on work progress and promptly addressing any issues encountered.
Cold Spring Brewing
Quality Control Technician/ Inventory Specialist
04.2018 - 04.2022
Job overview
- Provided training to many newly joined personnel in plant of 6 mfg running lines producing approximately 30,000 cans/line for testing procedures related to energy drinks, which encompassed batch analysis and assurance before manufacturing.
- This included conducting tests for total acidity, pH, and nutritional contents using HPLC (caffeine, benzoic, sorbic), as well as microbial counts (SPC, MY & Bacillus) pour plate or filter methods, tailored to specific customer requirements.
- Additionally, performed inventory inspections for quality control and production, which involved verifying availability and consumption through AX Microsoft system.
Eshyasi Pharmaceuticals Limited
Quality Control/ Assurance Executive
03.2016 - 11.2017
Job overview
- Conducted comprehensive API drug testing using techniques such as HPLC (Assay and Deg), Capillary TLC, and particle size analysis.
- Oversaw quality operations related to qualification, manufacturing, packaging, and release of finished goods, ensuring compliance with GMP standards.
- Authorized release of sanitized process rooms and equipment, conducted QA in-process checks, and verified equipment calibration.
- Played key role in preparing and reviewing SOPs and specifications, maintained accurate inventory and documentation, and actively participated in employee training. Addressed customer complaints, managed nonconformance reports (NCR), and implemented corrective actions (CAPA), ensuring adherence to quality standards and continuous improvement initiatives.
Ravi Plant Biotechnologies Private Limited
Quality Control Officer
09.2013 - 02.2016
Job overview
- Analysis & release of 10 to 15 raw material (Wettability, Suspension Check, LOD, KF) packing material (COFB Check), In-process manufacturing material, and finished goods (On HPLC, GC, Malvern, Viscometer) as per current SOP and customer's methods & specifications of BIS in SAP and ERP.
- New Vendor development and Vendor Audit for primary packing material and key starting material.
Education
Sardar Patel UniversityAnand
Masters from Biotechnology
05.2013
Sardar Patel UniversityAnand
Bachelor from Biotechnology
05.2011
Skills
- Project Management: Expertise in overseeing CMO activities, including preparation and maintenance of quality agreements
- Quality Assurance: Proficient in reviewing and approving quality management system (QMS) documents, including deviations, investigations, and change controls
- Regulatory Compliance: Knowledgeable in supporting regulatory inspections (FDA, DEA, VAWD, NABP, NJDOH) and ensuring adherence to quality standards
- Complaint Management: Skilled in handling product quality complaints and reporting on quality metrics to relevant teams
- QMS Support: Experienced in initiating and reviewing QMS activities, including CAPA and change controls
- Training and Development: Effective in training employees on quality management systems and processes
Microsoft Learning (Outlook, Teams, AX, Excel,Word, PP)
Aspire Online training software
Empower, Openlab (HPLC/GC Software)
Trackwise, 6sigma, 7QC tool
Instruments
- HPLC (Waters, Agilent 1220, Shimadzu2010 CHT, Youngling 6000)
- GC (Agilent)
- Dissolution apparatus (DISTEK 5100)
- Particle size analyzer (Malvern 3000 Dry & Wet analysis)
- Viscometer (Brookfield)
- UV visible spectrophotometer (Shimadzu, Perkin Elmer)
- TLC
- Karl Fischer Titrate (Metrohm, Ana lab, Veego Matic-MD)
Timeline
QA Associate
Glenmark Pharmaceuticals Inc.
05.2023 - Current
QC Chemist
Pfizer Inc.
04.2022 - 11.2022
Quality Control Technician/ Inventory Specialist
Cold Spring Brewing
04.2018 - 04.2022
Quality Control/ Assurance Executive
Eshyasi Pharmaceuticals Limited
03.2016 - 11.2017
Quality Control Officer
Ravi Plant Biotechnologies Private Limited
09.2013 - 02.2016
Sardar Patel University
Masters from Biotechnology
Sardar Patel University
Bachelor from Biotechnology
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