Quality Control Manufacturing

Skilled professional with hands on experience in chemical synthesis and manufacturing

Strong scientific and technical background in pharmaceutical chemistry, including method development, batch manufacturing, quality assurance, and production troubleshooting

Experience in NMR (C-13 and 1H), HPLC, UV, FT-IR, GC-MS, and LC-MS for pharmaceutical product analysis

Thorough understanding of GMP, GLP, validation and regulatory compliance requirements (US FDA and MHRA) for manufacturing

Education

London Metropolitan University, United Kingdom 2009-2010

Master’s in Pharmaceutical Science

Pune University, India 2004-2008

Bachelors of Pharmacy

Relevant Work Experience

Analyst Chemist 2010-2011

Pharmvit Ltd, United Kingdom

Testing of dosage forms, raw materials, intermediates and in process samples by using instruments such as HPLC and different spectroscopic methods and documenting work procedure and test results in compliance with, as per as various regulatory requirements.

Retain an up to date knowledge of analytical techniques and equipment and do calibration and maintenances in timely manner.

Did in-process checking and sampling of intermediate, bulk and finished product.

Ensuring periodic validation and re-validation related to process and instruments whenever required.

Well-developed project skills with strong trouble shooting and problem solving skills.

Ensuring documentation as per GMP, MHRA and ICH requirement.

Perform all activities in accordance with written safety procedures

Acquired a thorough knowledge of GMP and GLP

Production Chemist 2008-2009

Marck Biosciences Ltd., India

Responsible for:

oEfficient transfer and release of parenteral products

oCompounding to production

oDispensing of raw materials for manufacturing a batch

oIn-process testing

oMaintaining and completion of batch manufacturing records

oValidating procedures

oSterilization of manufactured batch in timely manner

Maintained a yield of 95-100% of the expected yield at end of manufacturing process

Investigated quality control issues with questionable/ problematic batches and documented findings

Performed necessary adjustments to prevent batch failure and ensured continuous production of parenterals

Wrote and implemented SOPs and quality control methods

Reduced production cost by minimizing the amount of waste material generated during each cycle of batch manufacturing

Maintained validation summaries and SOPs to ensure compliance with cGMPs

Successfully managed audit visits from US FDA, MHRA, and other regulatory bodies for approval and inspection of the manufacturing unit

Calibrated and maintained equipment to ensure continuous work flow without interruptions

Trained staff to load and unload of batch in sterilizer

Successfully introduced new and easy batch tracking/coding system for finished goods

Graduate Research 2009-2010

London Metropolitan University, United Kingdom

Comparative study for the syntheses of boranate and dialkylphosphonate esters as potent thrombin inhibitors

Synthesized potent thrombin inhibitors using boron or dialkylphosphonate derivatives

Prepared 10 different derivatives using phosphonate esters and were identified using separation and evaporation processes combined with quality control methods (i.e., C-13 NMR, 1H-NMR, HPLC, UV spectrophotometer)

Technical Expertise

C-13 and 1H (proton) NMR spectroscopy

Infrared spectroscopy (FT-IR)

High-performance liquid chromatography (HPLC)

Mass spectroscopy (LC-MS)

Gas chromatography (GC)

Column chromatography

Rotary evaporator

Sterilization methods

Separation techniques

Elution methods

Computational Skills

Proficient in Microsoft Office (MS Word, Excel, and PowerPoint)

ChemDraw, Sigma stat and statistical data software (SPSS)

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