Ultratech India Limited is a FDA, GMP & ISO certified manufacturer that caters to worldwide pharma markets for products across the pharmaceutical value chain ranging from a wide range of Pharmaceutical Formulations in various dosage forms ( Tablets, Capsules, Syrups, Injections, Nasal Sprays, Metered Dose Inhalers) to Active Pharmaceutical Ingredients and upto advanced drug intermediates.
Ultratech also provides Custom research and manufacturing services (CRAMS) and undertakes Custom Synthesis for new molecules, Process Development work of Bulk Actives as well as for Pharmaceutical dosages, Private labeling and Contract manufacturing.
Post: Regulatory Executive/ Officer
Job Description:
- To prepare the Drug Dossiers of various Pharma formulations
- To Provide speedy support in preparation of Dossiers and registration documents required for various countries.
- To co-ordinate with Q.C., Production & R&D department for preparation of Drug Dossiers of Pharmaceutical formulations
- To conduct reference study search in libraries / internet for accumulating comparative technical data of various Formulations.
- To check the Batch manufacturing records and documentation systems followed on various loan license manufacturing sites.
- To check inventory records of various LL sites
- To conduct site audits for LL manufacturing
- To check artworks
Candidate Profile:
Minimum 3 years in Q.A. Documentation for preparation of Drug Dossiers of a Formulations manufacturing unit
Experience: Past exposure in preparation of Drug Dossiers in a Pharma Formulations manufacturing unit. R&D, Production & Q.C. exposure in various sections like tablets / capsules / Liquid orals / injectables preferred
Interested candidates can send their updated resume on hrd@ultratechindia.com
Additional Information:
Experience: 3-4 years
Location: Mumbai
Education: B.Pharm, B.Sc, M.Pharm, M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: DRA
Contact: Ultratech India Ltd
119, JK CHambers,
Sector 17, Vashi Navi Mumbai
End Date: 7th July, 2011
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