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| Job Location | Mumbai City |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | ecruitment Services |
| Functional Area | R&D / Product Design |
| EmploymentType | Full-time |
Job For dra ANDA Api-manager job Profile: 1Scrupulous in filing of Drug Master File*/NDA/INDs for US and Europe (CEP and ASMF). (*DMF of APIs made-up from Synthetic, Semi-synthetic route and Peptides). 2Instrumental in Life Cycle Management and handling of Post approval changes for Drug Master Files (PAS/Type-II/Major, CBE-30/Type-1B/Minor, CBE-0/Type-1AIN/IN and Annual report). Key role in supporting Continuity of operations and Business critical changes for organization, which mainly includes process excellence changes proposed for - Quality improvement, Ease of operations, Facility modification and Cost effectiveness API. 3. Expertise in development of Quality Management System with full compliance as per ICH and current regulatory expectation. Key role in managing Change control, OOS Investigation, Event/Incident, Vendor Audit, Qualification and Validations and most importantly Quality Risk Management. 4Maintaining DMF compliance, handling DMF change notification and filing appropriate ANDA supplement to implement changes. Providing on time support to handle ANDA deficiencies. Coordination with commercial team to maintain Supply reliability for APIs. 5. Preparation of GRSD (Global Regulatory Strategy Document) and discussion with customers - GPO, RPO and LPO for finalization of change category and implementation plan from DP prospective. 6 Timely response of Deficiencies raised by regulatory agencies.7Key role in finalization of ROS, Specification of API, Intermediates and Starting materials. Planning of Carry over studies, Design of experiments based on QbD and Decision making for Acceptance criteria in coordination with Analytical development department. 8 Facilitate initial Desk study like, literature search for polymorphism, plausible impurities, degradation products, pKa, logP, pH dependent solubility and Melting point etc, required for PARA-III and PARA-IV (FTF) filings. 9. Key role in selection of Appropriate Regulatory Starting Material for DMF filing. Based on ICH Q11/Q7 and Q9 guidance. 10. Member of core team for vendor selection and audit, review of vendor documents in lieu of CMC (for advanced intermediate). 11. Comprehensive knowledge in review of Analytical Method Validation (HPLC, GC, ICP, IC, LC-MS, GC-MS etc.). Job For Review of Change controls, Events, Incidents and providing appropriate Regulatory strategy, Change category and Implementation plan for US, Europe and other regulated market.
Keyskills :
icphplcvalidationalidationsmethodanalytical