CIPLA Hiring Team Member - Formulation Tech Transfer M. Pharm (Analytical/Pharmaceutical Chemistry) Apply Now
Job Purpose
Execute analytical technology
transfer activities in the plant to ensure successful transfer to commercial
plant in line with defined safety norms, cost, quality and delivery timelines
for new product registrations driving on time commercial launch
Accountabilities
i. Perform effective transfer of
knowledge about the analytical process to Quality Control team with required
documentation for successful implementation of new molecule analytical process
ii. Review the Method validation,
Method verification, Specification and method of analysis and relevant
analytical transfer documents to identify and remove errors
iii. Review batch documents
(analytical reports) and initiate/ensures procurement of prerequisites (Column,
Impurity, working standards etc.) for batches execution to ensure alignment
with 6M Planner and Target filling date
iv. Participate in batch analysis
(feasibility, registration, assessment, validation, query response and first
three commercial batches) to ensure smooth execution.
v.
Compile batch analytical results and stability for RBDR (registration
batches documents review) to perform comparisons and compilations
vi. Provide technical inputs for
regulatory deficiencies to support RA to respond to queries efficiently
vii. Monitor the R&D and
feasibility batches at Pilot plant to understand the process
Education Qualification
M. Pharm (Analytical/Pharmaceutical Chemistry)
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