Dipal Patel

* **** ***

Morris Plains, NJ *****

732-***-****

ac5t12@r.postjobfree.com:ac5t12@r.postjobfree.com

mailto:ac5t12@r.postjobfree.com

OBJECTIVE:

Highly self-motivated individual, possessing extensive hands on experience in quality systems, quality assurance and quality compliance along with broad-base knowledge of GMP, GCP and 21 CFR. Seeks challenging position in an organization where my education and skills could be fully utilized to enhance my personal and professional growth.

SUMMARY

●Excellent team player with Management and problem solving and troubleshooting capabilities.

●Knowledge of GMP and FDA/ICH Regulatory guidelines, Audits, Good Documentations Practice. Quality Systems with Global sites.

●Excellent communication and inter personal skills.

●Excellent knowledge on CAPA and Deviations, Issuance of CAPA and investigate to the root cause right from the beginning to closing the CAPA.

●Excellent knowledge of USP, EP and ICH guidelines.

WORK EXPERIENCE:

Jan, 16 to Present Sr Regulatory Compliance Analyst Sanofi, Bridgewater, NJ

Lead the FAR team and work closely with FAR/BPDR, Product Quality Complaint, and Pharmacovigilance counterparts to help ensure clear communication in support of all Field Alert Reporting.

Support GMP compliance activities related to Field Alert and Biological Product Deviation Reports by maintaining compliance with all applicable GMP regulations and Tranings.

Working on a project for process improvement for the FAR (Field Alert Reporting) and PQC (Product Quality Complaints) teams.

Submissions of Initial and Final investigation report to FDA. Includes collection of all the data related to the product from related international manufacturing sites.

Trigger word activities within the Siebel FAR system in support of the Field Alert Team.

Field Alert / BPDR FA Review activities within Siebel.

Assist with GMP audit preparation (document request/retrieval, spreadsheet updates).

Compliance with SOPs and Work Instructions for all FDA regulated Field Alert / BPRD activities.

Compile and maintain monthly reports for department and audit of other sites. Issuance of Deviations and CAPA and follow up on those CAPA’s and make sure it is followed and closed in a timely manner.

Conduct detailed review of complaint and investigate the complaint by reviewing batch records, lab results and necessary documentations. And also performs close-outs of complaints.

Provide support to US Product Quality Complaints Managers/Director as needed.

Understand the FDA complaints regulations for the drug products and medical devices.

Interacting with US PV (Pharma co vigilance) team on cases.

Performs Metrix on monthly basis.

04/05-11/15 Owner US Cleaners, Caldwell, NJ

Owner and operator of three Dry Cleaners.

Managed over all operations of dry cleaning with a help of fifteen staff members and three managers.

Developed home delivery system for pickup and delivery of dry cleaning with 200 clients.

One of the first in the state to introduce pick up and drop off of dry cleaning at the store location at off business hours (Self Service).

08/03-03/05 Sr International Technical Analyst Schering Plough, Union, NJ

●Member of international change control team.

●Follow all the SOP’s in Global Quality Systems and movements of all change control documentations.

●Responsible to finalize the Technical Specification of all the Raw material and Finished products of 45 sites all over the world.

●Communicating with all the international sites to get all the necessary documentation and procedures to review their specification.

●Audit of procedures for global sites for their documentations. If not in compliance issue CAPA.

●Tracking of changes and leasing with various sites to make sure the change is implemented in a timely fashion with all the approvals.

●Review their process validation and their methods.

●Communicating with different international sites making similar products to ensure they are following same procedures and also making sure the specifications are in compliance with the local agency.

●Perform review of USP/NF, EP for upcoming changes and updates and making changes accordingly to the specification through change control.

●Update training documents and making sure all the updated trainings are completed by the relevant departments on all the International Sites Globally.

05/03-08/03 Quality Assurance OHM Labs, New Brunswick, NJ

●Inspected the production in compression, granulation and coating departments.

●Validations of Medical devices, IQ/OQ/PQ.

●Internal audits of facility and subcontractor facility.

●Approved tableting machines, de-duster and tools. Conducted in-process testing in the manufacturing department.

●Checked weight, thickness, hardness friability and disintegration time for compressed tablets.

●Maintained production batch records and familiarized with weighing, granulating, drying and final-mixing procedure.

●Audited entries in the cleaning, usage and sanitation logbook and ensured step-by-step completion of batch records

●Performing quality test on all the production products and it equipment’s.

08/02-05/03 Analytical Scientist OHM Labs, New Brunswick, NJ

●Testing of Finished Products samples and Raw Materials samples and Stability samples using USP/NF methods.

●Familiar with using HPLC, UV Spectrophotometer, IR, Dissolution apparatus, and other commonly used instruments such as pH meter etc.

●Worked on water sample analysis of Acid/Neutral/Base that includes Sampling and processing at two different sites.

●Responsible of maintaining of log books and temperature charts of the stability chambers at two different sites.

●Perform Stability studies of drug products for evaluation of expiry date.

●Responsible to take swab samples from manufacturing machines and Packaging lines before and after a new batch and process those swab samples according to the SOP.

EDUCATION:

1992-1995 B.S. Chemistry Gujarat University, India.

Major Courses: Analytical Chemistry, Organic Chemistry, Inorganic Chemistry,

Laboratory Techniques in Chemistry

1988-1991 Diploma in Chemical Engineering DDIT, India.

COMPUTER & SKILLS:

Fluent in Siebel, Microsoft Office and Project Management skill, Track wise.

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