Analista de Aseguramiento de Calidad I&d (Lima)

Primary Job Function: The function is responsible for providing QA support to the entire product development life cycle processes by ensuring related practices adhere to market(s) Health Authority regulatory requirements, international regulations as well as the Abbott Quality policies.

Core Job Responsibilities: 1. Initiate and support the investigation (LIR, Non-Conformities) related to the analytical activities of the Laboratory of the development center. 2. Ensure the integrity of the Data in the Development Laboratory. 3. Support the process of Development, Validation and Transfer of Analytical Methods. 4. Equipment Qualification Supervision. 5. Follow up on the stability study program. 6. Equipment Calibration Supervision. 7. Monitoring of equipment maintenance program. 8. Follow up on the compendial update process. 9. Supervision of the STARLIMS, EMPOWER, LABX and other systems that provide support to the analytical data of the laboratory.

Position Accountability/Scope: The function is accountable for quality culture and compliance on activities performed at the development center to ensure adherence to market(s) Health Authority regulatory requirements, international regulations as well as the Abbott Quality policies.

Minimum Education: Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area.

Minimum Experience/Training Required (recommended): 1. Comprehensive understanding of a wide range of Pharmaceutical Lifecycle, Development, Testing and Clinical Operations, Risk Management 2. Minimum 2 years combined experience in QA and/or Development/Operations/Pharmaceutical Engineering function in Pharmaceutical environment. 3. Knowledge of international and local pharmaceutical quality system and compliance, legislations and international and Abbott standards. 4. Risk based, perceptual and analytical thinking related to: setting priorities, empower people, creative solutions, resources and facilities involvement. 5. Postúlate en Kit Empleo: kitempleo.pe/empleo/y2lks