Kalyani Bhanja
Senior Executive at Bluefish Pharmaceuticals- Claim this Profile
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Bio
Experience
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Bluefish Pharmaceuticals
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Sweden
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Pharmaceutical Manufacturing
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100 - 200 Employee
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Senior Executive
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Sep 2019 - Present
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Apotex Pharmachem Inc.
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Senior reviewer II
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Sep 2014 - Sep 2019
Handling the APR team. Conducting weekly meetings and preparation of minutes of meeting. Sharing the information of Gaps and its assessments with the manager. Providing Training to new joinees in the team. Preparation of training matrix for the team and providing training to the team as per matrix Responding to queries to regulatory authorities Sharing document to cross functional teams Preparation of APR Schedule and allotment of work to team members. Compilation And… Show more Handling the APR team. Conducting weekly meetings and preparation of minutes of meeting. Sharing the information of Gaps and its assessments with the manager. Providing Training to new joinees in the team. Preparation of training matrix for the team and providing training to the team as per matrix Responding to queries to regulatory authorities Sharing document to cross functional teams Preparation of APR Schedule and allotment of work to team members. Compilation And review of Annual product Quality Review Trending of critical in-process parameter results and finished product results. Investigation of out of trend and out of specification results. Compilation of Summary of all sections related to APQR. Show less Handling the APR team. Conducting weekly meetings and preparation of minutes of meeting. Sharing the information of Gaps and its assessments with the manager. Providing Training to new joinees in the team. Preparation of training matrix for the team and providing training to the team as per matrix Responding to queries to regulatory authorities Sharing document to cross functional teams Preparation of APR Schedule and allotment of work to team members. Compilation And… Show more Handling the APR team. Conducting weekly meetings and preparation of minutes of meeting. Sharing the information of Gaps and its assessments with the manager. Providing Training to new joinees in the team. Preparation of training matrix for the team and providing training to the team as per matrix Responding to queries to regulatory authorities Sharing document to cross functional teams Preparation of APR Schedule and allotment of work to team members. Compilation And review of Annual product Quality Review Trending of critical in-process parameter results and finished product results. Investigation of out of trend and out of specification results. Compilation of Summary of all sections related to APQR. Show less
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Dr. Reddy's Laboratories
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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Associate
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Apr 2009 - Sep 2014
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Cipla
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India
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Pharmaceutical Manufacturing
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700 & Above Employee
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QA Officer
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Sep 2007 - Jan 2009
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Education
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Birla Institute of Technology and Science, Pilani
MS(Pharmaceutics), Pharmaceutical Sciences -
Hemwati Nandan Bahuguna Garhwal University
Bachelor of Pharmacy (B.Pharm.), Pharmacy