Resume

Sign in

Quality Medical

Location:
West Babylon, New York, United States
Posted:
May 16, 2018

Contact this candidate

Mahak Khan

Long Island, NY

ac5g85@r.postjobfree.com

929*******

Summary:

Experienced Professional with Years of experience working with Quality Assurance, Quality Control Documentation/ Regulatory team,

Education:

Master of Pharmaceutical Sciences, Department of Pharmaceutics, Jamia Hamdard University, India, 08

Bachelor of Pharmacy, Department of Pharmacy, Jamia Hamdard University, India, 06

Drug Discovery, Drug Development and Drug Commercialization (Certificate Courses), Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, 16

Regulatory Affairs Certificate in Pharmaceuticals, RAPS, Maryland, 17. RAC Experience:

QA/QC Document/Regulatory specialist –MTC Industries Inc, Long Island,NY 1st June 17- till date This is GMP certified FDA approved Company, dealing with hard tablets, Softgels, Capsules, Raw materials

(Active Pharmaceutical Ingredients)

Master File of products

Giving Approvals to Certificate of analysis, ISO, HACCP, FSSC22000 certifications.

FILLING and submission of Pharmaceutical companies Questionnaire, related to ingredients mentioned in Sepcification and COA.

Checking Regulatory Status of ingredients. Eg NDI, GRAS

Storing all documents as per SOP’s and providing it for every shipment or order.

Updating all certificates.

Giving Approvals to supplier of ingredients and checking all documents

Checking 3rd Party Audit certificates BRC, HACCP, ISO22000. Premier Brands of America- Bronx, New York 1st May 16 – 31st Oct 16 Quality Assurance Analyst

It Is GMP Certified FDA apparoved, dealing with Liquids, anifungal liquids, Antiseptic liquids and many more over the counter Medications in Spray, liquid forms.

Responsibilities:

Job responsibilities were passing batch of OTC product as per FDA guidelines, GMP 21 CFR 211, ISO 13485 ( OTC Drugs were manufactured in facility and packaging were done as per FDA regulations). I was checking ang giving approval to Routers Master Product records.

Checking Routers/ Batch product Records.

Sending complete paper works (Certificate of analysis, batch records etc) to our Clients globally before shipment begins, updating Standard operating procedures.

Wright Medical Technology, Kuwait 1st Mar 12 – 27th Feb 14 Medical Representative

Responsibilities:

Job responsibilities were checking all orthopedic medical devices and implants and present in operation theater with surgeons while they performing knee surgery, providing them with correct implants they needed. Kuwait Saudi Pharmaceutical Industry company, Kuwait 2nd Jan 09 – 31st Mar 10 Compliance Officer Quality Assurance department

Responsibilities:

Duties were to check all analysis performed my lab are under specifications and giving approval to pass the batch manufacturing records.eg, in vitro tests.

Updated Standard Operating Procedures as per guidelines, any consumer complaints reporting to R&D departments.

Checked and maintained Products stability studies. Kuwait Saudi Pharmaceutical Industry company, Kuwait 1st Oct 08 – 31st Dec 08 Quality Control Analyst/Quality Control laboratory Responsibilities:

Duties were to perform analytical tests on Finished products like tablet, capsules, syrups and I.V. fluids and in process products as per US pharmacopeia, checking product quality.

I have worked on ocular Microemulsions my project during masters was “cationic induced ocular microemulsion”



Contact this candidate