Ø  M.S. In Pharmaceutical Chemistry, with several years practical experience

Ø  Pursuing Regulatory Affairs Certification (RAC); offer broad domestic and global regulatory knowledge including: 21 CFR 210 and 211; ICH & FDA guidelines for both clinical and commercial products; IND, BLA, sBLA, CTD/eCTD requirements; NDA and ANDA filing

Ø  Expertise in analyzing, developing and updating broad range of documentation, methodologies, protocols, programs, records, and reports focused on Quality Assurance and Regulatory Compliance

Ø  Dynamic strategic planning, prioritization and project/workflow management skills; able to maximize productivity and efficiency in time-sensitive, quality-focused environments

 

 

Analytical Chemist, Applied Pharmaceutical Research-Middleburgh, NY                  Dec 2008-Current

Effectively manage high-volume of complex documentation in compliance with FDA and related regulatory standards; document samples analyzed on GC for In-House Method for Assay and USP method for free steroids

Create new SOPs and STPs as well as modify prior SOPs; comprehensively develop and validate analytical methodologies and documentation as well as prepare deviation reports if technical difficulties impede SOP implementation

Efficiently prepare qualification program for Instruments (IQ, OQ, PQ), new specification protocols for New Analysis method and batch record for Production

Successfully prepare and implement analyst qualification program

Adeptly maintain samples for Stability testing and supporting records

Actively meet with quality management in support of compliance objectives

Strategically planned, coordinated and steered workflow/projects to maximize use of time and resources in achieving critical schedules/deadlines

Productively maintain weekly inventory report for items supporting next two months of projected requirements

Proficiently manage instruments, including operation, calibration and troubleshooting of HPLC, GC, FTIR, UV- visible for analysis of raw material and finished product; responsible for KF Determination & GC Headspace for residual solvent analysis as well as Fraction Collector for preparative liquid Chromatography using 4 and 8 columns

 

Research Analytical Chemist, Arag Biotech Pvt Ltd.-Nagpur, India                   May 2006-June 2007

Conducted HPLC analysis of raw material and finished products as well as stability samples analysis; included method validation and documentation as well as routine analysis of tablets using dissolution and disintegration apparatus

 

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Yyyyyy x. yyyyyy                                                                                                             Page 2 of 2

 

Masters Degree, Pharmaceutical Chemistry, Fairleigh Dickinson University, NJ

Bachelor Degree in Pharmacy, India

 

Distance Learning Diploma in Regulatory Affairs; Pending

 

GMP and cGMP per 21 CFR part 210 and 211
FDA Safety Training, Good Manufacturing Practices

Hazardous Waste Disposal Training

 

 

1) S.W.Sewatkar, S.B.Ganorkar, K.K.Chandak, Dr. G.S.Bhoyar, M.J.Umekar Anti-microbial activity of plant of Chrysanthemum Indicum Indian Journal of Natural Products, Sagar. India; Nov-2007

2) D.M.Biyani, S.W.Sewatkar, A.W.Awandekar, S.B.Ganorkar Current Evaluation Pattern In Pharmaceutical Education- Pros and Cons Indian Journal of Pharmaceutical Education and Research; Jan 2008

 

 

Seminar Presentation: "Methacrylate Monolithic Columns and pDNA isolation and purification"

 

 

Member, Regulatory Affairs Professionals Society (RAPS)

Member, The Organisation for Professionals in Regulatory Affairs (TOPRA)

Registered Pharmacist, Pharmacy Council of India; Life Membership

 

 

Member, American Red Cross of Greater New York

Volunteer, instrumental in reuniting 22 child trafficking victims with their families

Participant, Plantation Program-Mumbai, focused on reducing greenhouse effect

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Date

 

 

 

Hiring Agent Name

Title

Company Name

Address

City/State/Zip Code

 

Dear__________________:

 

I am currently seeking a challenging career opportunity as a (INSERT TITLE OF THE POSITION) and am submitting my resume for your review.  In advance, thank you for your time and consideration.

 

As demonstrated in the accompanying resume, I offer solid qualifications in Quality Assurance and Regulatory Compliance gained through academics and training as well as several years of practical experience.  In my current position as Analytical Chemist with Applied Pharmaceutical Research, I have focused extensively on complex documentation, protocol, methodologies, reporting, records, and programs, and I am well-versed in ICH and FDA guidelines for both clinical and commercial products as well as a broad range of industry regulatory standards.  Complementing my M.S. in Pharmaceutical Chemistry, I am in the process of acquiring Regulatory Affairs Certification.  I have also completed  training in GMP and cGMP (21 CFR part 210 and 211) as well as FDA Safety/Good Manufacturing Practices training.  Additionally, I am published in pharmaceutical research and am a member of RAPS and TOPRA.

 

As an employee, you will find me to be a driven team player committed to supporting you in achieving your objectives through superior performance.  I am confident that I could be a valuable asset to your firm, and look forward to interviewing with you in the near future.

 

Sincerely,

 

 

 

Yyyyyy x. yyyyyy