Hands on experience in compiling and review of the dossiers for ASEAN Markets, AFRICAN Region, Middle East and GCC Region, LATAM Region including Brazil and Mexico. Well versed with CTD and ACTD dossier compilation and registration requirements.
Monitoring and technical support for execution of Packing equipment qualification,Trial,
Scale up, exhibit, commercial process validation batches on packing lines and handling of investigations, if any during the execution.
With minimal input from manager, manages multiple project assignments supporting Variations, Product Expansion dossiers, Renewals and regional projects simultaneously; MSR packages/documents will range in complexity
To be an integral part of an antibody development team with a focus on performance and specificity using innovative molecular, protein, and cell biology methods.
Review, assess and process Safety data and information, across service lines, received from various sources and distribute reports/data onwards to both internal and external third parties following applicable regulations SOPs and internal guidelines under guidance and support of senior operation team members.
Autonomous with strong self-motivation and ability to work independently as well as in a highly collaborative and multicultural environment within short timelines.
Preparation of additional information or responses as requested by regulatory agencies. Prepare or maintain technical files as necessary to obtain and sustain product approval. Direct the collection and preparation of laboratory samples as requested by regulatory agencies.
BRIC-Translational Health Science and Technology Institute (THSTI) is an Institute of the Biotechnology Research and Innovation Council, Department of Biotechnology, Ministry of Science & Technology, Govt. of India.
The ECHS Central Organisation is located at Delhi and functions under the Chief of Staff Committee (COSC) through AG and DGDC&W in Army HQ. The Central organisation is headed by Managing Director, ECHS, a serving Major General. There are 28 Regional Centres ECHS and 426 ECHS Polyclinics. ECHS is also an attached office of Dept of Ex-Servivemen Welfare (DoESW), Ministry of Defence (MoD) as are Directorate General Resettlement(DGR) and Kendriya Sainik Board (KSB).