Data Integrity and Validation Specialist
hace 4 días
About Grifols, S.A
Grifols is a global healthcare company dedicated to improving the health and well-being of people around the world. With over 110 years of experience, we have established ourselves as leaders in plasma-derived medicines and transfusion medicine.
We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment. Our diverse teams work together to drive innovation and deliver high-quality products and services.
About the Role
We are seeking a highly skilled Data Integrity and Validation Specialist to join our Quality Control Division. The successful candidate will be responsible for performing functions related to process improvements and general procedures in the Quality Control laboratories, specifically related to the validation of computerized systems, data integrity, and qualification of laboratory equipment.
Main Responsibilities
- Improve processes and general procedures in the Quality Control laboratories related to the validation of computerized systems, qualification of laboratory equipment, data integrity, risk analysis, etc.
- Prepare periodic technical reports detailing system validations and maintenance activities.
- Participate in the preparation/review of validation documentation for computerized systems of laboratory equipment.
- Provide support to the laboratories in activities related to data integrity.
- Deploy new procedures in the Quality Control laboratories.
- Work in a GMP environment ensuring compliance with regulatory requirements.
Requirements
- Bachelor's degree in Biochemistry, Pharmacy, Biotechnology, or a similar field.
- At least 2 years of experience in the validation of computerized laboratory systems in a GxP environment, with expertise in system development and validation activities.
- Knowledge of computerized system management principles, including GAMP guidelines, 21 CFR Part 11, and GMP Annex 11.
- Advanced level of English language proficiency (First Certificate or higher).
- Proficiency in MS Office, especially Excel.
- Knowledge of laboratory equipment software (Empower, Tiamo, Endoscan, or similar) and SAP or related ERP systems.
Benefits Package
We offer a competitive salary of $80,000 per year, flexible working arrangements, and a range of benefits, including health insurance, retirement plans, and paid time off. As a permanent employee, you will enjoy a stable and secure career path with opportunities for growth and development.
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