Job Description

JOB DESCRIPTION: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

• Masters 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 METAP-CIS/ APAC regions 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.
• Lead Technology Transfer of products to the region from EPD and/or I&D.
• Localization of the established and new products in METAP-CIS/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.
• Part of global product workstream for specific product which is widely manufactured in the region (METAP-CIS)
• 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.

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.

The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: ManufacturingDIVISION: EPD Established PharmaLOCATION: India
Salcette : Goa FactoryADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Yes, 25 % of the TimeMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott