We have urgent requirement for Documentation & Review in Analytical Development Dept.
Company: FTF Pharma Pvt Ltd
No. of Position: 01 (Female is preferable)
Education: M.Pharm
Experience: 4 to 6 years
Designation: Sr. Research Associate / Research Scientist
Please, find herewith the Job Profile for the said role.
- Protocol and report review of Analytical method validation and Analytical method transfer document of drug substance and drug product.
- To provide necessary analytical support for formulation development.
- To prepare Specifications and Standard test procedures of all regulatory market products.
- To Ensure GDP compliance in the laboratory.
- Data compilation with pharmacopoeias for the regulatory marketed product.
- Documents preparation of tech transfer activity.
- Change control activities & all other necessary document preparation for regulatory market products.
- Communication with the vendor for Active drug substance-related query, and any updation in the document; documents required for Raw material tech. transfer/change in ROS etc.
- Client query response and provide the necessary support for ease of project execution.
- Change control activities & query response for all regulatory queries raise at the time of filling of the drug product.
- Preparation and review of justification of specification for all regulatory marketed products.
- Preparation and review of Justification for impurities for all US marketed products.
- Preparation and review of Residual solvent compliance for all regulatory marketed product
- Preparation of Standard Testing Procedure preparation for NOC-form 29/STP for License.
- Preparation of CPS data.
- Drug master file (DMF) review.
- COA comparison for Drug substance/API.
- To train the subordinates for documentation and for GMP compliance.
Interested can share their CVs with hr@ftfpharma.com.
PLS. READ JD CAREFULLY BEFORE APPLYING. IRRELEVANT CVS ARE STRICTLY PROHIBITED.
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