Descripción del Empleo:
Resourse must provide quality compliance support for the following tasks and duties: Support related projects including review and approve proofs, change orders and labeling implementation activities.
Work with project teams (internal/external departments) to ensure that all projects, including appropriate documentation, are generated in compliance with Industry procedures, cGMP requirements and statutory requirements (US FDA, ISO, MDD and CMDR).
Provide Change Control QA requirements for labeling implementation related changes. Perform other related duties as required.
Education Bachelors is required. Chemical, Biomedical, Mechanical, or Industrial Engineering is preferred with 3 to 5 years minimum experience in an FDA regulated environment, preferably in Quality Assurance. Experience with Quality System Regulation (QSR), ISO, Design Control and Process Validation guidelines. Able to develop technical documentation (technical writing) such as: Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Change Controls, and others. Will have a fundamental understanding of a quality system and its development, documentation and implementation to domestic and international standards or requirements. Will be able to plan, control and assure product and process quality in accordance with quality principles.