Dileep Kumar Chintala
Validations Quality Assurance at Dr. Reddy\'s Laboratories
- Role
- Validations Quality Assurance at Dr. Reddy's Laboratories
- Location
- Vizianagaram Mandal, AP, IN
- LinkedIn followers
- 500 followers
About Dileep Kumar Chintala
A seasoned pharmaceutical professional with 11.8 years of experience in the Active…
Experience
Validations Quality Assurance
Dec 2020 — Present · Visakhapatnam, IN
Professional Experience:Handling of technology & Site transfer of the Peptides.Handling of development, trial and Process Validations and product development studies Handling of cleaning optimization, verification, and validation studies.Handling of Vendor quality management and qualification.Handling of Nitrosamine control strategies i.e chemistry and facility assessments and cleaning validations of NitrosamineHandling of Change controls, identifying them as minor or major. Handling of Hold time studies and stability management. Reviewing and approving of Development followed by trial and validation of manufacturing documents i.e. BPRs, Process flows, Protocols, and their respective reports.Reviewing and approving product/nitrosamine cleaning validation documents i.e. ECRs, Protocol, and their respective reports.Preparing, Reviewing, and approving product/nitrosamine cleaning validation MACO calculation cleaning matrixes.New product development & technology transfer coordination with plant CFT, R&D, and Development quality assurance.Reviewing and approving of R&D new vendor development and qualification use test protocol and reports i.e. KSM, advanced intermediates, intermediates, other raw material, and consumables packing materials. Highly skilled and results-oriented professional with experience in MES Recipe designing (Rockwell FTPS)Review and approving of recipes and workflows in MES.Reviewing and Approving the created equipment entities (Materials, Equipments. Users and workstations, classes).Exceptions review and troubleshoot the issues.Providing the training to the production team on approved recipes.Handled Pharma Applications:MES, SAP, LIMS Labware, LMS, DocHub, Change Control Management (SAP Fiori), DCMS (Deviation and CAPA Management system) & CLEEN (Leucinetech).
Education
Tata Institute of Social Sciences
B Voc
2014 — 2017
Dr. B. R. Ambedkar Degree College
Bachelor’s in Chemistry
2014 — 2017
Acharya Nagarjuna University
Master’s in Organic Chemistry
2017 — 2019
Maharajah's Government College of Music and Dance
Certificate course
2008 — 2011
Anurag Group of Institutions
Diploma of Education
2013 — 2013
ABRSM
Grade 1 Music Theory
2012 — 2013
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