Seeking suitable challenging position in Quality Control / Quality Assurance in pharmaceutical industry (EAD APPROVED).

WORK EXPERIENCE

Feb-2017 – Feb 2020

QA/QC Analyst at HomeoCare laboratories, Yonkers, NY

●Performing the Chemical test for all Raw materials, In-Process and Finish product & also performing Microbiogical testing and growth promotion test, validation testing etc.

●Stability testing of the Various Product.

●Assist in FDA Audit twice.

●Help in preparing all the FDA related document.

●Prepare Process Validation, Cleaning Validation, Machine Qualification.

●Instrumental analysis, method development and validation, preparation of SOP, review of SOPs as per USP, HPUS .

●Document Review as per cGMP

●Prepare SOP of Microbiological Laboratory

●To maintain the laboratory documents as per cGMP guidelines.

●Assist in maintaining good housekeeping of the laboratory.

●Provide support to other quality control function when necessary.

Ensure that tests performed & documents prepared are in a timely manner in accordance with Standard Operating Procedures

July/13 – July/15

Merril Pharma Pvt. Ltd. Plot No 212, Bhagwanpur, Roorkee, Uttarakhand 247667

QA/QC Chemist

●Quality Control Standard Testing Procedures review and approval

●Stability Testing,, preparation of SOP, review of SOP,

Aug/07–April/09

:

Borden Company(private)Limited, Borden centre, 9 Jalan Kilang Singapore 159409

Lab Technician/Assistant

●Performing the Chemical test for all Raw materials, In-Process and Finish product & also performing all test on various Instruments like Gas Chromatography, HPLC, UV Spectrophotometry

●To maintain the laboratory documents as per cGMP guidelines.

●Ensure all tests performed are in compliance with Quality Assurance system in laboratory and in accordance with cGMPs.

●Assist in maintaining good housekeeping of the laboratory.

●Provide support to other quality control function when necessary.

●Ensure that tests performed & documents prepared are in a timely manner in accordance with Standard Operating Procedures (SOPs)

Feb/07 –May/07

Volunteering helping research students at Analytical Chemistry

Laboratory in Chemistry Department Under Dr. Chanbasha Basheer in National University of Singapore

Aug/06 – Nov/06

:

Excel Healthcare Pvt. Ltd., Gujarat, India

QA/QC Chemist (Details : Annexure I)

●Quality control Standard Testing Procedures review and approval.

●Instrumental analysis, method development and validation, preparation of SOP, review of SOPs as per I.P, BP, Document Review as per cGMP

●Development of Dissolution method for non-Pharmacopoeia product and analysis of development batches.

●Stability studies for ongoing research projects.

●Prepare SOP of Microbiological Laboratory

●Sterility testing of parental preparation.

●Preparing reports and testing of packing material.

●Maintain all Laboratory documents as per cGMPs guidelines

Feb/06 – July/06

:

Orley Laboratories Pvt. Ltd., Gujarat, India. (Annexure I)

QC Chemist

●Preparing reports and testing of packing material.

●Maintain aseptic area for microbiological testing

●Check microbial limit and microbial assay of raw material, finish product

●Operate all laboratory instrument

●Fumigation, perform Microbiological assay for antibiotic tablet, capsule, liquid preparation, parental preparation, ointment

Internship Details

Project center : Maan Pharma Ltd., Gujarat, India

Project Title : Orientation of various departments.

Duration : 3 months.

Academic Profile

2001-2005

B.Pharm : Shri Sarvajanik Pharmacy College, Mehsana, North Gujarat University, India

Achievements

Approved Chemist - Food & Drug Control Admin, Gujarat State, India

Government Approval in Chemical & Physico Chemical Testing

Government Approval in Microbiology Testing

Registered Pharmacist - Gujarat State Pharmacy Council, Gujarat, India

Government Registered Pharmacist

Presentations delivered

●“Instruments used for the analysis of Anti Tuberculosis drugs at Excel Pharmaceuticals Pvt. Ltd. India.

●“Stability Testing of New Drug Substances and Products” at Orley Laboratories Pvt. Ltd., Gujarat, India

Personal Strength

Sound technical and professional skill to produce innovative solution as required.

Strong will to achieve the assigned task, good coordination with team members.

Good communication skills, Fluency in English.

References

(1) Dr. Indermeet Singh Anand, Head of Dept, Pharmacology, Shri Sarvajanik Pharmacy College,Mehsana, Gujarat. Ph.No. +912***-******. Email: ad1ibl@r.postjobfree.com

(2) Dr. Basheer chanbasha, Assistant Proffessor,Department of Department of Chemistry King Fahd University of Petroleum and Minerals

Dharhan 31261, Saudi Arabia. Email: ad1ibl@r.postjobfree.com

Annexure I

Responsibilities handled at previous employment:

Preparing reports and testing of packing material

Analysis of Raw materials, Intermediates, In-process and Finished products of Drug Substances by using validated instrumental and conventional methods,

Having good documentation knowledge of cGMP & cGLP.

Assisted preparation of Analytical Method validation protocols and validation of the analytical methods.

Maintenance and procurement of Reference standards, working standards and laboratory

Stability testing of R&D Products and interpretation of the analytical results.

Cleaning Validation of the manufacturing facility during Product change over.

Taken active participation during the Audits in the company. Having good documentation knowledge of cGMP audits.

Developed alternate analytical methods for existing Finished Products.

Check microbial limit and microbial assay of raw material, finish product

Maintain aseptic area for microbiological testing

Preparing reports and testing of packing material.

Fumigation, perform Microbiological assay for antibiotic tablet, capsule, liquid preparation, parenteral preparation, ointments.

Developed a laboratory procedure for preparation and tracking of working standards and the stability of the same.

Ms. Heena Patel

Contact Details:

11 LAKE STREET, APT 3K,

WHITE PLAINS, NY - 10603

Phone: +1-914-***-****

Email Address:

ad1ibl@r.postjobfree.com

Contact this candidate