Abbott QA Development and Technical Support Manager in Moscow, Russia
Primary Function/Primary Goals/Objectives
The QA Manager, Technical Support primary responsibility will include:
- Managing product and process quality and compliance throughout the life cycle from development to commercializationGuarantee the quality and compliance of the product and process during identification of the commercial manufacturing site and all the technology transfers and improvements.Guarantee the quality and compliance of product and process pre-commercialisation during development and clinical trialsProvide expert support to facilitate issue resolution for key investigation and compliance issues
Reporting to the Head of QA Russia, key responsibilities will include:
Ensures development / continuous improvement and implementation of GxP, PV and EPD QA requirements.
Responsible for ensuring that all the quality activities during technology transfer and development are timely completed meeting the business needs of the division and the Authorities and Corporate Quality Standards.
Implementation and maintenance of QMS for I&D and MS&T in Russian region.
Serve as technical resource of Russia EPD Quality organization during process and regulatory deficiency issues, risk assessment target cost initiatives and other continues improvement initiatives
Supporting the lifecycle management strategy and supporting its operational execution as member of the workstream team or equivalent cross-functional team.
Support the quality aspects of the Product Portfolio Expansion Initiatives and other Non-Centrally Supported Products
Key Quality contact during CMC activities including specification setting
QA project coordinator for products development and implementation projects
Subject matter expert for API supplier audit
Approver of stability programs and Technical Transfers Protocols
- Bachelor’s Degree or equivalent in life science
At least 5 years pharmaceutical experience in the fields of pharmacovigilance, quality assurance or regulatory affairs
At least 5 years of combined experience in QA, Operation, RA or Technical Function in Pharmaceutical environment
Expertise with regards to relevant PV/GCP/GLP/GMP regulatory requirements
Comprehensive understanding of a wide range of Pharmaceutical Manufacturing and Testing Operations.
Extensive Knowledge of international and local quality system and compliance legislations and standards.
Troubleshooting and issues resolution skills
Project management expertise
Perceptual and analytical problem solving related to: removal of obstacles, setting priorities, people, resources and facilities involvement.
Ability to communicate affectively, both orally and in writing for both technical and non-technical audience. Including National and International Health Authorities
Teamwork attitude and capability of understanding and overcoming different cultural and language obstacles to provide solutions satisfying corporate, divisional and local objectives.
Ability to use Quality Risk Assessment and Root Cause Analysis tools
Strong analytical skills and the ability to organize work in a logical, thorough and succinct manner.
Detailed knowledge of inspection and auditing standards
Extensive knowledge of PV and GxP regulatory requirements and industry best practices.
Flexibility to adapt to changing assignments and ability to effectively prioritize.
Project management, interpersonal, and communication skills and ability to work independently and as part of a team.
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