mohit deshpande

quality assurance

About

Lead job profile as to play the job-role as a audit co-ordinator from the site i.e: Pre-audit arrangement Audit schedule confirmation Audit coordinator / representative from site during inspection Compliance report preparation for the received observation report from the regulatory agency / customer audit / government authorities

Country

india

City

aurangabad

Industry

pharmaceuticals

Skill

validation, glp, pharmaceutical industry, capa, anda, v&v, sop, cleaning validation, pharmaceutical sales, regulatory affairs, gmp

Experience

quality assurance

national pharmaceutical industries muscat oman

2018-6 - Present · 8 yrs 4 mos

compliance-quality assurance

ipca

2015-12 - Present · 10 yrs 10 mos

Lead job profile as to play the jobe-role as a audit co-ordinator from site i.e:Pre-audit arrangement,Audit schedule,Audit co-ordinator / representative from site during inspection,Compliane report creation for the received observation report. Audit Faced till date with existing and previous organisation: 1.Mylan:WHO Geneva 2.Wockhardt: 2 times USFDA / 2 times MHRA /CDSCO /WHO. 3.IPCA:USFDA /Various Customer audit / regulatory audit Along with mentioned lead profile i have carried out below routine activities: 1.Vendor development 2.Review technical specification for new customers 3.Quality aggrement development for new custormers 4.QMS system through trackwise tool 5.Preparation of APQR 6.Regulatory affairs queries handling 7.Audit compliance for all regulatory /venodor /customer agency 8.Devaion /Change Control /Market complainte handling

qc officer

mylan laboratories limited

2011-9 - 2012-8 · 1 yr

* COA preparation, Change Control, Deviation raised and completed as per requirement. * SOP preparation as per required timeline. * Facing & success ding WHO GENEVA, and other Audits. Audit Faced: WHO Geneva CDSCO & various other country's regulatory inspection

compliance

wockhardt

2012-8 - 2015-11 · 3 yrs 4 mos

* Initiation And Closure Of Incident/Deviation With Proper Documentation * Preparation Of CAPA Reports, Handling Deviations And Preparing The Investigation Reports Of The Same. * Initiation And Closure Of Change Control With Proper Justification/Documentation * Initiation and Review of COA’s for Regulated and non regulated markets of API, Excipients, Packing material & finished products * Preparation, Co-Ordination, Revision And Implementation Of Sops, Specification, STP As Per Pharmacopeia Updation (USP38NF33,BP,IP) And Various Types Of Formats Related To SOP . * Timely dispatches of responses to queries received from Health Authorities of different countries. * Coordinating With Regulatory Affaires And Fulfilling Their Requirements With Respect To Filling Of New Drug Products And Annual Updating. * New SOP Prepared And Introduced As Per Current Requirement Of QMS/cGMP System with Training Conducted And SOP made effective. * Preparation Of Annual Product Review. Audit Faced: 2 times USFDA 2 times MHRA WHO CDSCO & Various other regulatory country audit