Quality Control Assurance
Resume:
Girish Lad
Jersey City, NJ *****
Objective:
Seeking for the position in pharmaceutical field while merging into a globally focused organization that will purposefully utilize my qualifications while offering several opportunities to integrate personal enrichment with professional goals.
Education:
Master of Engineering in Pharmaceutical Manufacturing
Stevens Institute of Technology, Hoboken, NJ
Course Work: Project Management, Bioprocess Technology in API Manufacturing, Validation and Regulatory Affairs in Pharmaceutical Manufacturing, cGMP and Biopharmaceutical Facility Design, Design and Management of Aseptic Pharmaceutical Manufacturing Processes, Modeling and Simulation for Pharmaceutical Manufacturing, Process Analytical Technology and Lean Six Sigma
Bachelor of Pharmacy
Rajiv Gandhi University of Health Science, Karnataka, India
Course Work: : Pharmaceutics, Inorganic Chemistry, Organic Chemistry-1, Organic Chemistry-2, Physical Pharmaceutics, Pharmaceutical Microbiology and Biotechnology, Pathophysiology, Applied Bio Chemistry, Medicinal Chemistry-1, Pharmaceutical Engineering, Pharmaceutical Jurisprudence, Pharmacognosy and Phytochemistry, Pharmacology, Pharmaceutical Technology and Biopharmaceutics, Instrumental and Biomedical Analysis, Medicinal Chemistry-2, Industrial Pharmacognosy etc
Certifications:
• Certified Pharmacy Technician (PTCB)
Summary of Qualifications:
• Deep knowledge of monitoring procedure
• Deep knowledge of Assay studies.
• Deep Knowledge of Estimation Studies.
• Knowledge of process validation and regulatory affairs.
• Understanding of TLC and HPLC methods.
• Detailed knowledge of cGMP and ICH guidelines including basic understanding of regulatory requirements.
• Comprehensive knowledge of Covance S.O.P.'s for site monitoring.
• Basic knowledge of clinical trial process.
• Basic knowledge of clinical and hospital pharmacy.
• Basic Knowledge of pharmacokinetic and Therapeutic Drug monitoring (TDM)
Skills:
Lab Skils: Experience For Doing Essays, Estimation, Monograph analysis, Titration, Limit tests.
Manufacturing: Process Simulation and Optimization, Design of Experiments (DOE), Quality by Design (QbD), Process Analytical Technology (PAT), FMEA, Six Sigma and Statistical Process Control (SPC) Tools (Histogram, Pareto Charts, Control Charts, Cause and Effect Analysis), SOP and Document writing, Equipment Calibration and Qualification, Protocol Development and Execution, Clean-In-Place System Design
Validation: Validation Protocol and Reports, Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualification (PQ), Cleaning Validation, Documentation, Calibration Protocol and Report Writing
.
Guidelines & Regulations: Working knowledge of FDA (21 CFR Part 11, 210, 211, and 600), OSHA (29 CFR Part 1910), EPA, ISPE, ASME (BPE-2007), ICH (Q7, Q8, Q9 and Q10)
Graduate Projects
Manufacturing of chocolate chips by applying cGMP
• Manufacturing of chocolate cookies with quality by design and six sigma approach.
• Prepare SOPs and documentation (Quality Policy, Validation Protocol, Validation and Master Batch Records and Process Development Reports) as per regulatory requirement and save them in M.file.
• Supported pre-approved inspection of product.
User Requirement Specification (URS) for Stopper Sterilization
• Create URS for stopper sterilization.
• Prepare Bid request package for stopper sterilization which includes URS, bid Request Schedule, cost estimation form and cover letter.
Installation Qualification (IQ) and operation Qualification (OQ) for Electronic Range
• Prepared Installation and Operation Qualification Protocol.
• Performed Installation and Operation Qualification.
Experience:
Graduate Research Assistant Aug ‘11 – May 12
Stevens Pharmaceutical Research Center, Pharmaceutical Manufacturing Department, New Jersey
• Performed a Validation of Autoclave (Equipment Qualification and Validation)
o Wrote a Validation protocol (Installation, Operational and Performance Qualification)
o Performed Validation with Biological Indicators and Temperature Mapping
o Submitted report in M-Files with comments
• Worked on Naphthalene recovery by Total Organic Carbon (TOC) Analyzer (Cleaning Validation))
o Derived and Calculated a method for preparation of Naphthalene Solution
o Used different combination of Methanol and Ethanol for solubilization of Naphthalene
o Took the swabbing samples and run in TOC Analyzer
Quality Assurance Engineer Jan ’12 - May ’12
Stevens Institute of Technology (SIT), Pharmaceutical Manufacturing, New Jersey
o Studied FDA, ICH and WHO Guidelines for Manufacturing and Quality
o Provided guidance in preparing of SOPs and Documents
o Assured that no compliance issue is overlooked
o Ensured that testing of any protocols or document created by the team is done appropriately
o Reviewed and Approved total 64 SOPs and Documents in this project
o Maintained all documents as per regulatory requirements and highest quality in Electronic Document Management Systems (M-Files)
AASHUTOSH PELLETS PHARMACEUTICALS, GUJARAT, INDIA
March 2010-September 2010
Production Supervisor
• To promote department goals by selecting, motivating and training staff and perform individual contributor task.
• To coordinate with ware house and trouble shooting of manufacturing, quality assurance and quality control department.
• To interprets specifications, prints, and job orders to workers, and assigns duties.
• To ensure that all products that are assign to them will be made into grain.
• To ensure that the output is in good quality and have a good record of the work so that they are missing out on productivity.
• Production, packaging planning and implementation.
ASIAN DRUGS AND PHARMA, NAVSARI, GUJARAT, INDIA
December 2010- June 2011
QA/QC Chemist
• To promote department goals by selecting, motivating and training staff and perform individual contributor task.
• Prepared BMR and various documentation as per USFDA guidelines and CGMP norms.
• Worked extensively on Dissolution Apparatus I & II and Disintegration Apparatus for Quality Control Testing of Solid Dosage Forms.
• Prepared Solutions and Dilutions as per the test requirements by Senior Chemist to perform HPLC analysis.
• Responsible for analyzing compounds as given and interpretation of those results.
• Worked extensively on Dissolution Apparatus I & II and Disintegration Apparatus for Quality Control Testing of Solid Dosage Forms.
• Performed Calibration of analytical instruments like UVVis Spectrometer, pH meter.
• Worked extensively on Dissolution Apparatus I & II and Disintegration Apparatus for Quality Control Testing of Solid Dosage Forms.
References:
1) Prof. Elaine Pratt.
Industrial Pharmacy,
Stevens Institute of Technology,
Hoboken, NJ
******.*****@*******.***.
( Green Card Holder)
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