Scope of the Role:
Sourcing and procurements of RMIs, depending upon the project priorities from domestic vendors. Resolving technical and commercial issues by coordinating with internal customers (R&D/Kilo-lab/Pilot Plant/Commercial plant/CM team/QA, etc.) and vendors.
Day-to-day interactions with scientists (CRD/DRA/AD/QA) to understand their actual needs and ensure procurement goals are met for in-house API development for various markets.
(A) Key departmental objective is to arrange RMIs and other key scientific inputs at the best possible cost from technically approved vendors globally in the shortest possible time to facilitate the early launch of products.
(B) Key Individual Role is to validate & procure indigenous RMs from technically sound domestic vendors at the best possible price & technical documentation, within specific timelines to facilitate early synthesis & development of new APIs.
Quality Operations (compliance, relevant activities, major end results of this job, etc).
1) Sourcing for Lab/Kilo lab development
a) To develop and validate sources for all New /unique RMIs from Domestic markets for lab development of in-house molecules.
2) Sourcing for Pilot & Exhibit campaigns
To validate sources at plant QA for procurement of new domestic RMIs initially for pilot plant-Toansa and detailed qualification for Exhibit batches.
3) Support on project costing
To explore reliable sources & provide bulk cost for unique RMIs to CRD for initial costing & cost-effective synthetic route finalization. (For in-house API developments & IP fencing)
4) Regulatory Support on RMIs
a) At the R&D stage
Provide COA, MOA, ROS, Impurity Profile, RS, Stability data, etc. (full TDP)
b) At Plant: provide various documents to qualify RMIs at the Pilot & EB stages
New RMI code creation (fill MCRF), VDQ (key & non-key), Quality Agreements (KRMs & Key Reactants), TSE/BSE, 3-batch CRD approved COAs + performance data, plant certifications (ISO/GMP), Quality Policy, MSDS, Stability data, etc.
a) Customer base – providing continuous feedback to internal (scientists) & external (vendors) customers on their areas of interest/concerns, e.g., RM costing & delivery status, payment status, etc.
6) Vendor development
a) To continuously explore & develop new vendors for sourcing RMIs for new APIs, Process developments (TD/TIG) & Impurity profile groups
b) Continuous co-ordination between vendor and R&D on harmonization of Specs/STP, resolving technical issues, matters related to QA compliance, responses to pre & post-filing queries
7) Achieve Cost Savings through:
i) Source Variation – Identify & validate cost-effective new sources for existing RMIs
ii) In-house sourcing, iii) Substitution of imported with domestic sources.
8) MIS / Database
Create the database for approved sources of all domestic RMI sourcing for various projects for effective control & future reference.
9) Source Variation :
Develop new/alternate indigenous sources in new CRD projects for commercially procured RMs at the plant
10) Others Areas relevant to the function
SAP related: for new RM codes/views / new vendor registration
Co-ordinate with pilot plant, plant stores, R&D-Stores, and Logistics for receipts / GRNs
SSC & CMA for timely release of payments to vendors