Founded in 1983, Sun Pharma IS NOW THE 5th Largest Manufacturer of Generics in the World, and No1 Company in India. Sun Pharma has above 40 Manufacturing Facilities in compliance with Regulatory Bodies like USFDA, MHRA, TGA, etc.
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Position: Executive/Sr Executive/Sr Officer – Formulation – Injectables
Location: Vadodara, Gujarat, India
Job Description:
M.Pharm. (Pharmaceutics) with about 2 – 6 yrs experience in R&D product development with injectable product development that includes liquid, lyophilized and complex injectables.
- To conduct a Literature search and Patent search for assigned projects.
- To procure raw materials (API / excipients), packaging materials, and innovator samples in consultation with the packaging/purchase department.
- To fill form 29 for the grant of manufacturing license for the purpose of Examination, Testing, and Analysis.
- To perform pre-formulation and formulation development trials with the QbD approach and therefore to develop a robust formulation.
- To manufacture batches for stability studies and write experiments in Laboratory Notebook.
- To prepare Technology Transfer documents like MF, Development Study Report, Risk Assessment, and FMEA.
- To review analytical reports and prepare compilation sheets and discuss results with superior.
- To co-ordinate with cross-functional departments like ADD, RA, QA, Plant for project/product related activity.
- To prepare SOP’s related to systems and laboratory equipment’s
- To be familiar with regulatory guidelines.
- To execute scale up/ exhibit batches in support with superior.
- Comply with the systems and SOP’s while execution of experiments.
- To prepare stability protocol and load the stability batches
- Review the stability batches data and report preparation.
- Preparation of specification proposal with justifications
- Address the regulatory queries
Qualification: M.Pharma – Pharmaceutics
Experience: 1-6 Years in R&D, Product Development, Lyophilized and Complex Injectables
Salary: Negotiable
Contact Details:
Mr. Vignesh Iyer
hrd@sunpharma.com, vignesh.iyer@sunpharma.com
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