Quality Assurance Manufacturing

Amit Shah

* **** ****** # ***

Spring Valley, NY 10977

845-***-**** (Home)

845-***-**** (Cell)

E-mail: *********@*****.***

______________________________________________________________________________

Objective: Creative and results-oriented pharmacy professional, seeking a job for a suitable Regulatory Affairs/Research position

Education:

Bachelor of Pharmacy

1995 The M. S. University of Baroda, India

Experience:

July 2010 – January 2011

Siemens Healthcare Diagnostics, Tarrytown, NY

Regulatory Affairs Associate

Technical ability:

• Worked for Class I, Class II & Class III - Chemistry and Hematology related Medical Diagnostic products such as Reagents, Calibrators and Controls

• Prepared New Product Registration Reports, Clinical Evaluation Reports and Renewal reports for China’s SFDA

• Reviewed USFDA’s 510k to extract information for China’s Report

• Preparation of Performance Evaluation Reports, Stability Reports to support the shelf life claim, Reference Range Validation Reports, Collection of the Substantial equivalence information (similarities in the new device and predicate device) etc.

• Worked closely with China RA team to determine and finalize requested information, clarified SFDA requirements

• Worked with R&D department to request information and documentation per China’s requirement

• Worked with the clinical group to obtain needed clinical information, clarified any data or documentation, and worked with department to resolve any informational or documentation gaps

December 2004 – October 2009

Silarx Pharmaceuticals, Inc, Spring Valley, NY

Senior Associates, Regulatory Affairs/ R & D

Technical ability:

Regulatory Affairs - Preparation and compilation of ANDA documents (CMC section and Labeling section) in electronic CTD format for liquid oral ANDA products.

• Preparation of manufacturing documents such as Manufacturing Process Validation Protocols and Reports, Post Approval Protocol, Proposed Batch Records (up to 10 folds), equipment comparison chart, etc.

• Preparation of Stability Protocols and Reports, Compilation and Review of Analytical Method Validation documents such as Standard Test methods, Test related data, etc.

• Compilation and Review of Raw material test methods, test data, Process validation or method transfer data, etc.

• Reviewed ICH Guidelines for Impurities and Stability requirements, Reviewed Drug Master File (DMF) for Submission related matters, Reviewed USP and European Pharmacopoeia for Standard Test methods and other requirements.

• Preparation of packaging materials documents, Preparation of side by side label and carton comparison, Review and update information for package inserts

• Independently Prepared Modules 1, 2 and 3 of ANDA Submission in eCTD format.

• Preparing Amendments, Supplements and Annual Reports for ANDA’s.

• Preparing and Maintaining Change Control documents as per the SOP and Current FDA guidelines.

Research & Development - To co-ordinate research & development activities relating to pre-formulation evaluation and development of formulation for liquid oral dosage form.

Pre-formulation:

• Conducted pre-formulation testing such as specific gravity, pH, taste and flavor.

Formulation:

• Inactive ingredients selected based on FDA’s inactive ingredient database, Compatibility Study data and Patent related information.

• Designed and conducted pilot scale, and large scale formulation trials for ANDA products.

• Pilot Scale Formulation Trials: Designed and conducted small (batch sizes: 1 Liter to 15 Liters) batches, for evaluation of drug-excipient compatibility, stability, and understanding other physical properties.

Multi-tasking ability:

• Managed multiple projects in support of departmental plan: Independently planned, managed, and completed technical programs necessary to design, development and optimization of new products.

• Coordinated with other departments to ensure smooth transition of projects into commercial production. Creatively linked formulation science and technology opportunities to the needs of the business through development/transfer of new products/formulations from inception to commercialization.

cGMP / Documentation / Regulatory ability:

• Well versed in cGMP requirement for the pharmaceutical industry and proficiently executed GMP manufacturing of several projects in pilot plant.

• Played an active role as a team member of different teams that are formed to update the Formulation development area, manufacturing area and quality assurance area as per cGMP requirements.

• Worked with different cross-functional teams including formulation development, analytical, regulatory affairs, regulatory compliance, project management, quality, R & D future team, commercial future team, and R&D operations on several projects to develop new products and bring them to the market.

• Wrote and reviewed SOPs, change controls as well as other documents, and participate in training. Communicate with outside vendors as needed to generate and review raw material and excipient specification sheets. Maintained precise experimental records; issued reports at project milestones.

September 2003 to November 2003

Silarx Pharmaceuticals, Inc, Spring Valley, NY

R & D Chemist

• Development of formulation for liquid oral ANDA’s

• Maintaining manufacturing records

January 2002 - June 2002

Glessener Pharmacy, Covina, CA

Pharmacy technician (Licensed Pharmacy Technician)

• Providing good customer services

• Handling prescriptions

• Attending phone calls

• Billing to the insurance company

Additional Abilities:

• Continuously look for ways to do things faster and better

• Helping customers with OTC products

• Honest team player (Performance with Integrity)

• Able to work independently

• Excellent problem solving skills

July 1998 to December 2001

Kesha Medical, India

Pharmacist

• Providing good customer services

• Managing pharmacy store employee

• Managing store

• Handling pharmacy orders

• Handling prescriptions

• Attending phone calls

August 1995 to June 1998

M. J. Pharmaceuticals, Halol, India

Manufacturing Chemist

• Manufacturing of tablet/ capsules by following cGMP regulations

• Participated in all activities such as preparation of SOP’s

• Trained new operators / technicians and supervised their work.

Ideas / Innovations:

Presented following ideas:

• Continuously provide ideas for new product and for product line extension.

Languages: English, Gujarati, Hindi (conversational)

Computer Skills: Microsoft Office (Word, Excel, PowerPoint, Project) and other Windows software

Reference: Available upon request.

Contact this candidate