Abbott Specialist Product Quality Assurance & Compliance - Temporary until December 2019 in Rome, Italy
Primary Job Function
The function will provide quality support in the Product Quality Assurance & Compliance team for all new and commercialized products with global/multiregional scope within the team structures of EPD. It will support projects and transfers associated with pharmaceutical Drug Substances, Intermediates and Finished Products.
Ensure manufacturing network optimization projects and transfers are executed according to timeliness, legal, Abbott Quality & Regulatory and international requirements. Liaise with different QA organizations and ensure proper communication and coordination within EPD QA. Provide support to facilitate issue resolution for key investigation and compliance issues
Core Job Responsibilities
Support Quality-related activities within all Product and Method Transfers at all EPD sites and TPMs Provides product Quality Assurance support and ensures quality compliance within the global project team structures. Promote the application of risk management principles for preparing decisions. Supports the resolution of investigation of any compliance issues during projects execution. Support QA activities as a part of regulatory filing preparation to achieve a smooth approval. Support Abbott documentation update and creation to keep Abbott system aligned with regulatory activities. Facilitate change management Supports team goals with cross functional/global scope.
Within the scope of this role are all the Core Job Responsibilities associated with product quality assurance of new and commercialized products of global/multiregional scope.
Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area. Master Degree desired.
Minimum Experience/Knowledge Required
Minimum 3+ years combined experience in QA and/or Development/Operations/Pharmaceutical Engineering function in Pharmaceutical environment. Previous experience in product transfers is a plus.
Knowledge of EU GMP and other international legislations and standards, e.g. PIC/S, WHO, ICH.
Troubleshooting and issues resolution skills.
Previous experience in Quality Control (QC) is desirable
Ability to communicate effectively, both orally and in writing to both internal and external audience.
Ability to use Quality Risk Management tools.
Fluent English; knowledge of other language is a plus
Ability to travel in all continents (10%)
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com