Job Title:   Quality Projects SpecialistPrimary Function / Goals / Objectives

As Quality Project Specialist, you will be reporting to the Regional Quality Manager within the International Third Party Manufacturing Division of Abbott Nutrition.   The role will have responsibility for the on-going Quality support of Business as Usual Third Party Manufacturer relationships and initiation of new business accounts as directed by the Regional Quality Manager to augment the Abbott Nutrition network through the provision of third party nutritional solutions.

Major Responsibilities

Establish and maintain robust long-term working relationships with new and existing Third-Party Manufacturers and material suppliers

Provide necessary training to the Third-Party Manufacturing team on Abbott expectations

Ensuring compliance to Quality Management Systems including complaints, batch release, exception reports, CAPA, document control, training, quality/performance metrics etc in relation to Japan Drug or Food business

Drive cross functional assessment for change control in accordance with regulation changes, requests from suppliers or Third-Party manufacturers.

Write and revise SOPs, controlled forms, and related documents to ensure best practices and alignment with current operations

Collate and report up key metrics on a weekly / monthly / annual basis and provide recommendations for improvement based on interpretation of data

Use problem solving tools to conduct and support investigations as they arise from product complaints or other sources from the quality system ensuring root cause is determined and appropriate CAPA actions implemented

Negotiate with Third Party Manufacturer on Quality Agreements

Participation on Cross Functional Project Teams to co-ordinate all Quality deliverables associated with the project milestones to include but not limited to ingredient and packaging qualification, facility readiness, equipment and utility qualification, process and test method validation, First Lot to Stock readiness and execution and registration

Using Quality Planning tools, lead and deliver quality system improvements and projects as assigned locally or from Global teams.  Track and report both financial and compliance progress to management and the project team leader. 

  

           

     

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 TPM QA and Operations Mangers. 

Education Required:

Bachelor’s Degree in a Quality, Pharmacy, Science, or Food related discipline. 

Knowledge:

A minimum of 5 years relevant work experience at least 2 of which is in the Japan Drug or Food business

Extensive knowledge of Japan GMP requirements with previous experience demonstrated

Excellent problem-solving and technical writing skills with experience in the use of problem-solving tools with demonstrated sense of urgency

Fluent in written and spoken Japanese

Advanced level written and spoken English

Excellent communication and presentation skills

Excellent attention to detail and accuracy

Enthusiastic and energetic with the ability to collaborate and deliver measurable improvements

Accountability / Scope

The position impacts directly on product quality and thus the financial and regulatory exposure of decisions could be significant.

The position has scope for decision making within confines of agreed responsibilities. Activities broadly defined by agreed goals. Supervision is received through meetings and one on one meeting with the Regional Quality Manager.  Periodic goal reviews, annual performance and career development reviews will also occur.

- End of Document -