Quality Control Analyst Resume Edgewood- NY - Hire IT People

SUMMARY

Master’s graduate in Regulatory Affairs working as RA & QA Associate for a Pharmaceutical Company with multifaceted roles such as compiling ANDA’s, Label preparation, Drug Listing, Publishing. Experienced in QC Lab as Analyst for 1 year.

Sound Knowledge in submissions of Drugs and Biologic applications (IND, ANDA, NDA, IMPD, MAA,) as per FDA and EMEA regulations.
Sound working knowledge on Module III (CMC/Quality) & QOS Module II (Quality overall summary) of ANDA’s in eCTD submissions.
Experienced using Pharmaready ( Software) for compiling of eCTD compliant document.
Knowledge on CBE, CBE-30, Annual reports, Amendments, Annual product review, safety reports and NDA field alert reports, CAPA ( Corrective and Preventive action), Recall plans, TPP ( Target Product Profile), SPA ( Special protocol Assessment) & OPDP regulations.
Knowledge in EU regulations for Variations, Renewal of MA, Annual reassessment, PSUR (Product Safety update Reports), Conditional marketing authorizations.

EXPERIENCE:

RA & QA Associate (08/2011- Current) - Confidential,Edgewood- NY
Responsibilities:

Compiling Module II and CMC (Module III) for ANDA’s in eCTD format under RA Head supervision.
Proposing and justifying acceptance criteria of related substances/impurities not listed in USP for drug substances/ products as per ICH Q3A & Q3B recommendations.
Preparing, review and proofread Label, package insert, Bottle labels for Rx and OTC products in reference to RLD and Monitoring and updating the labels for any changes in FDA website with respect to RLD.
Preparing SPL format of the label with the final approved label copy after review from the RA Head.
Authoring and Publishing the electronic submissions such as ANDA’s in eCTD format, Drug Listing for OTC products under distribution in SPL to FDA through ESG Gateway Systems by eCTD complaint software ( Pharmaready).
Interacts with cross functional teams( Product development, QC Lab, CRO) for getting required documents to support regulatory submissions.
Requesting and reviewing the Residual Solvent Certifications, analytical test results for container closures, cGMP & debarment Statements from Vendors, Obtain financial disclosures & 1572 from Investigators of Bio-study for ANDA submissions.
Preparing protocols for analyzing the active and inactive raw materials, finished products and packaging materials.
Preparing and updating RA & QA SOP’s when needed and reviewing requests from QC for Change controls and performing the necessary with justification as per Regulatory requirements.

Quality Control Analyst (06/2008 - 07/2009) - Confidential,India
Responsibilities:

Analyzing raw materials such as API’s (Active Pharmaceutical Ingredient) & Excipients samples by using various analytical instruments such as HPLC, UPLC, KF Coulometer, FTIR, UV-VIS spectroscopy and Dissolution testing’s.
Wet bench analysis by Loss on Drying, Polarimetery, Residue on Ignition, Melting points and pH tests.

Education:

MASTER’S IN DRUG REGULATORY AFFAIRS
BACHELOR’S IN PHARMACY

CERTIFICATIONS AND HONORS:

Registered Pharmacist certified by PCI (Pharmacy Council of India).
Certificate of completion for courses (Drug Review Process, Bioequivalence & GLP Inspection Program offered by FDA).
Honored by Rho Chi Society (Pharmaceutical Society) for academic excellence and is an active member.

Skills:

Pharmaready for electronic Regulatory submissions, SPL (Labeling, Drug listing) , CMC ANDA, eCTD, hyperlinking and Bookmarking, MS Office (Word, PowerPoint, Excel) & Adobe Software.

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Quality Control Analyst Resume

Edgewood-, NY

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