Cipla, as an organisation has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.
Post : Team Member - Formulation Tech Transfer
Job Description
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
Candidate Profile
• M. Pharm (Analytical/Pharmaceutical Chemistry)
• 2-5 years of experience in Analytical method development and transfer with sound practical knowledge of analytical Instruments such as (HPLC, UPLC, GC, GCMS, Autotitrator, Zetasizer, Mastersizer, Dissolution apparatus, IR, Coulter counter for particulate matter test, Viscometer etc.)
Additional Information
Job ID : 42289
Qualification : M.Pharm
Location : Madhya Pradesh - Indore
Industry Type : Pharma / Healthcare / Clinical research
Functional Area : Formulation Tech Transfer
End Date : 30th October, 2020
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