Data Integrity Specialist
hace 2 días
We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions. Grifols is committed to equal employment opportunities that foster an inclusive environment.
About the RoleThis position will perform 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.
Responsibilities- Make improvements to 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.
- 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.
- Participate in the deployment of new procedures in the Quality Control laboratories.
To perform this job successfully, you must have a Bachelor's degree in Biochemistry, Pharmacy, Biotechnology, or a similar field. Experience related to Pharmaceutical Industry Laboratories and work in a GMP environment will be valued.
Requirements- A minimum of 2 years of experience in the validation of computerized laboratory systems in a GxP environment.
- Knowledge of computerized system management: GAMP guidelines, 21 CFR Part 11, GMP Annex 11, etc.
- An advanced level of English (First Certificate or higher).
- Advanced knowledge of MS Office, especially Excel.
- Knowledge of laboratory equipment software (Empower, Tiamo, Endoscan, or similar) will be valued.
The estimated salary range for this position is $80,000 - $110,000 per year, depending on location and experience.
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