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 manufacturing issues to avoid the supply chain disruption.
Support the product localization considering cost estimates// regulatory requirement,, business plans, timelines and contingency plans for responsible projects in areas of CIP/ Alternate Vendor Development/ Gross Margin Improvement/ Supply
Review of dossier/ tech pack that supports the department in providing rapid and accurate evaluation of new business opportunities like in licensing/ co-marketing.
Minimum Education Qualification for the role
Post Graduation in Pharmacy (Pharmaceutical Science)
Minimum Experience/ background for the role
Sound knowledge of formulation development (Research development), manufacturing process (understanding of commercial equipment), Hands on experience with Alternate source qualification for API, Excipients (functional non-functional) and packaging materials.
Core Responsibilities
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.
Reach out to global product support work streams to have the desired technical support for the global product in the region has the responsibility for the coordination of technical support for products outside the globally coordinated work streams.
The responsibilities of this role include the technical support for internal and external manufacturing within the region as below:
Operational technical support to ensure product reliability, support portfolio growth, cost improvement by optimize.
Supporting the regional technical group along with the local technical groups at each of the manufacturing sites and for continuous growth of the technical organizations teams across the region.
Support for projects, e.g. Technology transfers, ASQ (API Supplier) qualifications, Localization Programs, Gross Margin Improvements, etc.
Oversight to all technology transfer related activities related to mfg. process.
Support for continuous improvement projects, process, formulation development improvements, remediation, and validation) and responding to technical issues resulting from manufacturing, compliance, or regulatory issues (Biowaiver, IVIVC technical justification based the regulatory query).
Review Support for technical Duediligence.
Review Support for regional Licensing Acquisition technical DD.
