*JOB OFFER BY BIOSENCE LLP – QC& DRA Sr. Executive FOR GURGAON & MUMBAI*

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 *JOB OFFER BY BIOSENCE LLP – QC& DRA Sr. Executive FOR GURGAON & MUMBAI*

Preferably 5-7 years of experience in a related department

SALARY: 50-70K 

Candidate should be responsible:

• To review the dossiers in format of CTD / ACTD and specific formats as per the respective country’s guidelines.

 To review the artwork (Labels, literature & mono cartons & pack insert) of the product according to the guidelines.

 Review and follow up of Administrative Documents (FSC, COPP, TRADEMARK, etc.)

• Responding to queries raised by MOH of the regions in stipulated time frame.

• To be able to coordinate with plants to get the Dossiers/Technical documents and samples of products for registration.

• To review the technical (COA, PVR, PDR, BMR, STABILITY STUDIES, AMV etc.), the documents for preparing dossier.

• To check the availability of the dossier and able to make new dossier with same available data.

• Well versed with ICH Guidelines. • To evaluate and comment about requirements of Clinical studies.

• Should be able to prepare raw data for dossier. Mandatory Skills and qualifications

.Desired skills:  • Exposure to Drug Regulatory Affairs. / • Knowledge of Schedule M drug / • Proactive approach to problem solving. / • Thorough Knowledge of GMP Practices.

• Good computation Skills. / • Fluent in English (Speaking, writing, reading, and understanding) / • Computer Skills (Ms. Excel, Ms. Word, Internet, Email)

ELIGIBLE MAY SEND CV BY WHATSAP 9152361109 / 9820597057 ultimatehr27@gmail.com 


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