dolly sharma

regulatory affairs manager

About

Consulting for QMS development and establishment at client site for ISO 13485:2016 & ISO 9001 :2015 Preparation of CE related technical documents. Provide training to client on QMS , CE, GMP etc. Mock audit for ISO, CE etc.

Country

india

City

ahmadabad

Industry

medical devices

Skill

validation, quality system, gmp, quality assurance, medical devices, iso 13485, sop, quality auditing, quality management, life sciences, fda, regulatory affairs, microsoft excel, pharmaceutical industry, hplc, healthcare, microsoft word, customer service, glp, molecular biology, powerpoint, microbiology, management, capa, regulatory requirements, documentation, quality control, iso 9001, biotechnology, corrective actions, iso, iso 14971, testing, pharmaceutics, r&d, change control, iso 9000, iso 14001, research, data analysis, preparation of technical file for ce certification, iso 9001, preventive actions, gas chromatography, laboratory, 21 cfr part 11, regulatory submissions, root cause analysis

Experience

ra manager

maven profcon services llp

2018-4 - Present · 8 yrs 6 mos

ra assistant manager

sahajanand laser technology ltd

2017-6 - 2018-3 · 10 mos

Handle QMS Prepare Technical documents for company registrations.

senior officer qa

meril life sciences india pvt ltd

2012-7 - 2015-5 · 2 yrs 11 mos

qa executive

mylan

2015-11 - Present · 10 yrs 11 mos

QA executive, looking after ISO 13485 implementation & technical documentation.

regulatory affairs manager

maven profcon services llp

2018-4 - Present · 8 yrs 6 mos

* Prepare Technical documents for CE certification of various medical device organizations. * Prepare and consult for QMS development and establishment at client site. * Mock audit for CE and QMS

Education

st joseph school

p.m.patel college

microbiology

sardar patel university, vallabh vidyanagar

pune university

sardar patel university, vallabh vidyanagar

2003-1 - 2008-1 · 5 yrs 1 mo

sardar patel university, vallabh vidyanagar

microbiology

2010-1 - 2012-1 · 2 yrs 1 mo

Accomplished the dissertation research on Incidence of Renal function disorder and Prevalence of anemia amongst Adults Tribal Sickle Heterozygote under the guidance of Director of Valsad Raktadaan Kendra, Valsad Dr. Yazdi Italia as a course curriculum of final sem. M.Sc (Micro)