Walk in interview in ARD, REGULATORY AFFAIRS at Panacea Biotec | M.Pharm
Panacea Biotec is a leading research based Health Management Company, with an annual turnover of approx. Rs. 830 Crores. We are engaged in research, development, manufacture & marketing of Vaccines, Bio-Pharmaceuticals and Pharmaceuticals (Rx & OTC) of international quality and Health Services. All Panacea Biotec plants are accredited by international agencies and they follow current Good Manufacturing Practices, as per WHO guidelines.
EXECUTIVE / SR. EXECUTIVE / ASST MANAGER - ANALYTICAL RESEARCH & DEVELOPMENT - 4 posts
QUALIFICATION & EXPERIENCE : M.PHARM in Pharmaceutical Chemistry / M.Sc.in Analytical Chemistry - with relevant experience of 3-7 Years.
• Method development for analysis of finished products like oral and injectable products like liposomes, nanoparticles.
• Analytical method validation and verification for finished product and raw materials.
• Analytical Technology transfer to QC. Maintenance of GLP activity in lab.
• Analysis of API, Excipients, finished products, stability samples like oral and injectable dosage forms.
• Method development for additional product characterization tests for liposomes/nanoparticles.
• Routine calibration and Maintenance of analytical instruments like HPLC, GC, disso apparatus, IR, UV etc.
• Preparation ofvalidation protocol, validation report, STPs, CoA, stability reports.
• Daily Upkeep of laboratory equipment, usage logs and lab note books.
SKILL SET REQUIRED : Should have experience in handling of sophisticated instruments like HPLC, GC, Particle Size Analyser, KF etc & interpretation of data.
EXECUTIVE / SR. EXECUTIVE - REGULATORY AFFAIRS - 2 posts
QUALIFICATION & EXPERIENCE : M.PHARM in Pharmaceutics / PG Diploma in Drug Regulatory Affairs with relevant experience of 3-7 Years.
• Working for the post approval life cycle management of approved ANDAs US/EU Dossiers and data compilation and coordination with internal and external stakeholders.
• Dossier compilation in CTD format for subm ission to ICH region (US,EU & Canada) and other regions such as Australia, NewZealand etcfor solid ora Is dosage forms.
• Document compliance of different dossier documents for adequacy and accuracy. It includes mainly CMC Documents, Vendor document. Pharmacokinetics study protocols and reports.
• Coordination with all involved parties in a product life cycle in product development, dossier compilation, query phase and post approval changes. Well verse witheCTD and SPL (Structured product labeling).
• Management of dossier data and updating scientific information within organization in the field of regulatory.
• Impact analysis on submitted dossiers during assessment phase due to change in regulations or requirements.
• Liasoning with project management team for maintaining timelines for dossier submission.
• Dossier document review, correction, adequacyand accuracy check.
• Coordination with other internal and external parties in dossier/query compilation stage.
SKILL SET REQUIRED : Should have handled Injectable / Solid Oral with knowledge of regulatory guidelines.
WALK IN INTERVIEW
Date : May 14th 2017 SUNDAY
Venue : Panacea Biotec Ltd., Grand R&D Centre, Plot No : 72/3, GEN Block, TTC Industrial Area, Mahape : 400710 Mumbai
Send their applications at email@example.com
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