Job Description
Purpose of Role
Minimum Education Qualification for the role
Minimum Experience/ background for the role
Core Responsibilities
- Support Established Products technical functions in MEAP and APAC region for Abbott manufacturing facilities and TPMs.
- Provide technical support to cross-functional teams during test method development, validation, transfer, or problem solving for a given drug product primarily of Biosimilars & Injectables.
- Experience in handling HPLC, UV, GC, Electrophoresis, ELISA, Peptide mapping, Bacterial Endotoxins, Bioburden, Sterility, HILIC UPLC, Real time PCR etc
- Provide technical support to ensure Operational activities for product continuity, product reliability, portfolio growth, cost improvement (optimize).
- Analytical method development, validation, and troubleshooting related to established products and new products within the regions (METAP-CIS/ APAC)
- Analytical support for Technology Transfer of products to the region from EPD and/or I&D.
- Localization of the established and new products in METAP and APAC Region.
- Provide Due Diligence support for business deals for new products.
- Co-ordinate with the global product support work streams to support completion of global product strategies and regulatory changes/updates in the region including GeoEx projects.
- Management and maintenance of Analytical Laboratory at MS&T Goa site, including Instrument/equipment installation, qualification, maintaining compliance according to global EQD standards.
- Preparation of Validation/verification/test method transfer protocols & reports, justification reports & deficiency letter response to the corresponding authorities. Evaluation of analytical gap assessments, impact assessments and providing the appropriate strategies to overcome such gaps/impacts.
- DARIUS Co-Ordinator for MS&T, Goa site.
Supervisory/Management Responsibilities:
