SUSHRUT SHARMA

**-***-**** ***# ***, ** St Alphonsus Street, Boston, MA-02120 ac24d3@r.postjobfree.com

Professional Experience

Zimmer Biomet (CMF and Thoracic) Jacksonville, FL

Co-op (QA/QMS/QE) Aug 2016 – May 2017

Non- conformance (NCR) management. Reduced the total Non- conformances (NCR) for Zimmer Biomet by 60%. Eliminated 90% of the aging non- conformances (NCR) backlog.

Owned, managed and completed 30% of total CAPAs (Corrective and Preventive Actions) for Zimmer Biomet. All the CAPAs were completed in a timely manner and were effective. CAPA processes included technical writing, documentation, and investigation in all the phases (ex- verification of effectiveness, corrective actions etc.).

Supported and worked on Issue Evaluations (CAPA determination) that were created due to a trend or audit findings.

Worked on the project to build gauge/product quality inspection routines for all the product lines (for CMF and Thoracic); including receive and final inspection.

Managed and worked on software validations and supported special process/equipment validations by writing validation plans and IQ/OQ/PQ plans/reports.

Supported and worked on project to establish a new quality management system for commercial off the shelf products for Zimmer Biomet, CMF and Thoracic.

Proficient with ISO 13485, ISO 14971, 21 CFR 820, GD&T, FDA regulations for medical devices.

Managed Overall Change Documentation process to pace up the documentation updates associated with CAPAs, Non conformances or other high priority projects while maintaining GDP.

Developed and revised Work Instructions, standard procedures, inspection criteria and Quality Manual documents for aforementioned activities. Provided training on documentation updates as necessary.

Eli Lilly and Company Gurgaon, India

Internship Feb 2015 – April 2015

As an intern with Eli Lilly’s Indian division I performed primary market research to determine the obstacles to launching clinical trials in India and benchmarked my findings with global regulatory bodies (USFDA, ASEAN, EMEA etc.).

Panacea Biotech New Delhi, India

Internship (R&D) May 2013 – July 2013

Supported a research project in development of multivalent pneumococcal-conjugate vaccine (downstream processing) by:

Working on HPLC, Affinity based chromatography and gel filtration chromatography to purify proteins, polysaccharides and glyco-conjugates.

Supporting coupling chemistry projects to couple CRM197 (carrier protein) with various polysaccharides of Streptococcus pneumoniae.

Education

Northeastern University Boston, MA

Masters in Regulatory Affairs for Drugs, Biologics and medical devices Sept 2015 – Sept 2017

GPA 3.681

Core knowledge regarding 21 CFR 820, ISO 13485, ISO 14971, cGMP, FDA regulations for medical devices.

Amity Institute of Biotechnology Noida, India

B.Tech in Biotechnology July 2011- July 2015

Engineering in Biotechnology. Minor: Microbiology and Immunology

Worked on a research project to find a novel highly conserved peptide sequence in human alpha defensins which helps in understanding the evolutionary relationship amid insects, plants and primates.

Skills

EtQ, Microsoft Office, MeasurLink, Tip QA, Infor-AS400, Infor-XA, Root cause analysis; risk assessment.

Certifications and Publications

“Readings in Global Health” from Harvard School of Public Health

Omics and its applications in Clinical Nanotechnology and Nano-Diagnostics; Renesha Srivastava, Sushrut Sharma, Prabhanshu Kumar, Pankaj Suman and Pranjal Chandra (accepted) in Kim S.-K (Editor) “Marine Omics: Principles and Applications” CRC press USA, 2015

Biomedical Applications of Marine Sponge: Sushrut Sharma, Renesha Srivastava, Pankaj Suman and Pranjal Chandra (accepted) in Ramjee Palella (Editor) "Marine Sponges: Chemicobiological and Biomedical Applications", Springer, 2016.

LINK: http://link.springer.com/chapter/10.1007/978-81-322-2794-6_16

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