Ankur Shukla
Regulatory Affairs/ Quality Assurance
- Role
- Quality Assurance at MANKIND PHARMA LTD
- Location
- Jaipur, RJ, IN
- LinkedIn followers
- 500 followers
About Ankur Shukla
Regulatory Affairs
Experience
Quality Assurance
Nov 2017 — Present
Responsible for effective handling of document management system to ensure required documentation and data are on-site for audits and inspections of regulatory agency/customer. Reviewing of Exhibit Batches/validation batches records for Audits/Regulatory filings. Participate and assist in internal/external audit program of Quality Management system. Organizing internal audits to ensure compliance and sound functioning of the process. Responsible for preparation/review of SOPs/procedures and effective implementation. Preparing and generating various reports / documents and forwarding the same to the management for decision making process. Sampling and dispatch related activities. Change Control, Deviation and CAPA in QAMS. Assist in the preparations, maintenance and indexing of regulatory archives.
Education
Padmashree Institute Of Mgt. Studies
Master of Technology - MTech, Nutraceuticals and Food Processing
2014 — 2015
Integral University, Lucknow, Uttar Pradesh
Major Project, Nanotechnology
Sikkim University, Gangtok
Bachelor of Technology - BTech, Biotechnology
2009 — 2013
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