SENIOR MANAGER QUALITY PROJECT LEADER – TPM – HATHRAS – ABBOTT

CREATING
LIFE-CHANGING TECHNOLOGY

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ABBOTT AT A GLANCE

We create breakthrough products – in diagnostics, medical devices, nutrition and branded generic pharmaceuticals – that help you, your family and your community lead healthier lives, full of unlimited possibilities. Today, 115,000 of us are working to make a lasting impact on health in the more than 160 countries we serve.

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Primary Function / Goals / Objectives

Senior Quality Assurance Manager supporting our Nutrition business. Reporting to the Quality Manager (Portfolio Expansion) based in Ireland, this stand-alone role is Mumbai based.

The role will have responsibility for the continuous improvement and execution of the start-up project QA activities while maintaining compliance with all applicable Quality system standards and regulations as well as Abbott policies and procedures.

This position is responsible for leading best practice quality assurance excellence and ensuring compliance standards are upheld at our third-party manufacturing sites in India.

MAJOR RESPONSIBILITIES

  • Establish a robust long-term working quality relationship with new third party manufacturers.
  • Provide necessary training to the Third-Party Manufacturing team on Abbott Expectations.
  • Participate in Site Assessment or Site Qualification Audit preparation, conducting audit and follow-up on Corrective actions.
  • Negotiate with Third Party Manufacturer on Quality Agreement.
  • Be responsible for overall quality and safety of our products manufactured:
    • identify and resolve key quality issues including issues for our products related to design, manufacturing quality programs and product start-ups
    • ensure Ingredient/packaging supplier approval and compliance at the TPM
    • support disposition of product batches, facilitate investigations, troubleshoot and resolve quality issues in close cooperation with the AN TPM Operations team
  • Integration of Abbott’s expectations and requirements into the Third-Party Manufacturers procedures in compliance within the Abbott quality system
  • Ensure accurate documentations are provided on timely basis for Product registrations.
  • Provide metrics for management review meetings, monthly reports etc.  Provide recommendations for improvement based on interpretation of data.   
  • Ensure project QA activities are documented. (e.g. Non-Conformances, Deviations and Quality Assessments, to division and global policies.)
  • Ensure compliance of quality system documents including, and procedures using established tools including Rubric.
  • Liaise with various functions / departments within Abbott and coordinate activity with the manufacturer on behalf of regulatory, R&D, procurement, package engineering, and many more internal stakeholders.    

SUPERVISORY/MANAGEMENT RESPONSIBILITIES: 

The position has no direct reports however the role has the potential to evolve into a leadership role as the business continues to grow and evolve. 

The position will require establishing close working relationships with both internal TPM QA and Operations Managers and external groups. 

KNOWLEDGE:

  • A minimum of 10 years relevant work experience at least 5 years in Science based company preferrable Nutrition or Dairy Industry with practical knowledge of project management.
  • Excellent understanding of Food safety with previous experience in a Quality auditor role a distinct advantage.
  • Excellent understanding of Quality Assurance principles.
  • Thorough knowledge of manufacturing processes (spray dryer, Aseptic and Retort technology) is a plus.
  • Excellent problem-solving and technical writing skills with experience in the use of problem-solving tools.
  • Excellent communication and presentation skills.
  • Excellent attention to detail and accuracy.
  • Innovative and Continuous Improvement mindset.
  • Certified Green belt in lean / six sigma would be advantage.
  • Experience within a Global, multi-cultural organisation.

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