Educational qualification : MSc (Organic chemistry) with 8-10 years' experience in API Regulatory affairs.

Greetings from Wikata Consulting Services Pvt Ltd-

Please find the JD below and revert-


Educational qualification : MSc (Organic chemistry) with 8-10 years' experience in API Regulatory affairs.



1. The candidate would be responsible for review of DMF's of outsourced API's as well as Company's in-house API's as per GDUFA requirements and other International Regulatory Agencies.

2. Having a background in organic chemistry and knowledge of synthetic and semi-synthetic processes and potential impurities and polymorphs which can arise from these processes.

3. Should be able to understand mechanism of reactions.

4. Should have thorough understanding the requirements and selection of KSMs.

5. Should be able to understand analytical methods development and validation requirements.

6. To work in close co-ordination with other RA team members for all projects.

7. Responsible for conducting literature searches in order to understand potential impurities and polymorphism in synthetic and semi-synthetic processes.

8. Responsible for communicating this information to stakeholders like R&D, Sourcing and follow-up's on procurement status of impurities.

9. Responsible to liaise with companys in-house API process lab as well as CRO's manufacturing impurities to determine availability of said potential impurities.


Thanks & regards,

Gurpreet
HR Executive- Talent Acquisition

104- First floor, Modi Heights
Ratu Road, Ranchi- 834005
landline-9334312121