*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