- Providing technical support to Abbott manufacturing facilities and Third-Party Manufacturers (TPM s) in the region.
- Collaboration with Manufacturing, Supply Chain, Commercial, Quality Assurance and Regulatory Affairs is critical to the success of this role.
- Troubleshoot the commercial issues to avoid the supply chain disruption.
- Support the product localization considering cost / regulatory requirement.
- Evaluate, uphold, and provide technical expertise for Compliance related topics and activities.
- Developing expertise within the region to support ever expanding product portfolio and related support to the cross functional team.
Minimum Education Qualification for the role
Master s degree in Pharmaceutical Science / Post Graduation in Pharmaceutical Sciences.
Minimum Experience/ background for the role
- Expertise in Analytical method development, validation and troubleshooting.
- Knowledge of statistical principles and application.
- Expertise in Quality compliance and Pharmacopoeia standards.
- Sound knowledge of the latest trends in global Regulatory benchmarks and standards.
- Sound communication skills with knowledge of technology driven tools.
- Agile enough to adopt the strategy based on the presented challenges.
- Willingness to travel and provide on-site support.
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 development, validation, transfer, or problem solving for a given drug product.
- 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.
- Analytical support for Technology Transfer of products to the region from EPD and/or ID.
- 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 MST 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 MST, Goa site.
Supervisory/Management Responsibilities:
- Validation Manager for MST, Goa site.
- Analytical Laboratory Manager, MST, Goa.
- Talent development to expand the analytical expertise within the region.
