Kalpana Mukherjee
Assistant Qa Manager @Aishwarya Group
Signup · Get unlimited contacts
WORK HISTORY
Assistant Qa Manager @Aishwarya Group
Sikkim, IN
EDUCATION
APJ Abdul Kalam Technological University
Master, M.Pharma (Pharmaceuticals), Pharmaceutical Sciences
Dr. A.P.J. Abdul Kalam Technical University
B.Pharm, Pharmacy
Dr. A.P.J. Abdul Kalam Technical University (AKTU), Lucknow
M.Pharm (Master's degree), Pharmaceutical Sciences
ABOUT KALPANA MUKHERJEE
The quality assurance professional is having around 14+ year’s progressive experience in API, OSD and Injectable organization in regulatory work environments. I am serving the organizations to achieve excellence for the organization and self with total dedication\'s, devotion & dynamism to grow with the organization by focus on establishing a culture of continuous improvement to perform assigned tasks with the highest quality and in accordance with established internal timelines. SKILL REGULATORY EXPOSURE FOR AUDIT i.e. EMA/EU, USFDA, MHRA, WHO, PMDA, UGANDA, ANVISA, IDMA. cGMP / ISO QMS internal and external Training Certified Lead Auditor (ISO 9001:2015) AQA, IPQA, QMS & Risk-based review and regulatory compliance. My core competencies include establishing and implementing Quality management systems, Quality audit compliance, Investigation of cGMP failures, Process validation, QMS (Change management, Nonconformances/ Deviations, OOS/OOT, Cleaning Validation, chairing quality review meeting based on quality risk management, AQA, IPQA, Qualification etc.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.