Brief Job Description:
1) Experience in Formulation R&D product development with experience in injectable product development includes liquid, lyophilized and complex injectable.
2) To procure raw materials (API / excipients), packaging materials and innovator samples in consultation with packaging/ purchase department
3) To conduct Literature search and Patent search for assigned project. Familiar with Regulatory guidance’s
4) To prepare application for form 29 and form 11 for the grant of Tet license and Analysis and import of RLD
5) To execute pre-formulation and formulation optimization trials with QbD approach and therefore to develop a robust formulation
6) To manufacture batches for stability studies and write experiments in Laboratory Notebook
7) To review analytical reports and prepare compilation sheet and discuss with superior.
8) To co-ordinate with cross functional departments like ADD, RA, QA, Plant for project/product related activity.
9) To prepare Technology Transfer documents like MF, Development Study Report, Risk Assessment and FMEA Execute scale up and EB batches
10) Preparation of product development report (PDR), elemental RAR Nitrosamine RAR and extractable RAR.
11) Address the regulatory queries
Venue of Interview: Sun Pharmaceutical Industries Limited Sun Pharma Road, Tandalja, Baroda – 390012
Note: Candidates having above experience can walk in with their updated cv, last degree, PAN, Aadhar card and current CTC proof at the venue
