Head office of “Ananta Medicare Ltd” is situated in the centre of London, in business district Fulham, United Kingdom. The company specializes in manufacturing, marketing and distribution of medicinal products of high quality at affordable process for all categories of customers in pharmaceutical markets of Europe and Asia.
“Ananta Medicare Ltd” has occupied exceptionally firm positions in the countries of CIS, in particular, in the market of Ukraine. Medicinal products of the company are well-known and enjoy confidence of both patients and doctors for more than 10 years.
Post: Drug Regulatory Affairs Manager
Job Description:
Supervision of production activities and ensure that products are manufactured, tested and released conforming cGMP and other regulatory requirements at the manufacturing sites. Conduct product and process quality checks following SOP.
Maintain all documentation to current standards & needs, and continuous improvement of the documentation system and data management process.
Dossier compilation in CTD format for submission to Ukraine and other CIS region.
Coordination with all involved parties in a product life cycle in product development , dossier compilation, query phase and post approval changes.
Impact analysis on submitted dossiers during assessment phase due to change in regulations / requirements or changes made by API manufacturer in ROS.
Management of dossier data and updating scientific information within organization in the field of regulatory.
To visit pharma plant at Haridawar, Roorkee for quality checking of the Production.
Candidate Profile:
Should have strong acumen to oversee production operation and ensure that products are manufactured, tested and released conforming cGMP and other regulatory requirements.
Should have QA background on the floor with knowledge of cGMP
Working knowledge in production of tablets/capsules/SVP/LVP/Liquid orals etc. will be of advantage.
Check/review documents as per regulatory requirements (variations/additional questions/reports)
• Write variations, additional questions and reports
• Act as a CRO-contact for outsourced analytical work if required.
• Co-ordinate and follow up for registration documents from manufacturing sites as per CIS regulatory requirements.
Should possess adequate knowledge of Regulatory requirements of CIS countries and Expertise in preparation of dossiers for Russia, Ukraine, Belarus and other CIS countries as per current CTD guidelines.
• Maintenance of lists/documents/records
• Strong analytical skills, inquiring and problem solving mindset
• Strong communication skills and able to work closely with people in wide variety of disciplines at different levels within the organization.
Additional Information:
Location: Delhi
Experience: 4-5 Years
Education: B.Pharm, B.Sc, M.Pharm
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
Last Date: 24th March, 2012
Send CV to: hr@anantamedicare.in
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