Abbott

Scientist (Analytical)

Abbott Mumbai Metropolitan Region

Purpose of Role

  • 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 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

  • Validation Manager for MS&T, Goa site.
  • Analytical Laboratory Manager, MS&T, Goa.
  • Talent development to expand the analytical expertise within the region.
  • Seniority level

    Associate
  • Employment type

    Full-time
  • Job function

    Production and Manufacturing
  • Industries

    Hospitals and Health Care

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