CSV & Data Integrity Specialist
hace 2 semanas
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.
We believe that diversity adds value to our business, our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.
We are looking for a Specialist Technician in the validation of computerized systems and Data Integrity for the Quality Control Division of Instituto Grifols SA, a company specialized in the research, development, and production of purified plasma proteins with therapeutic properties obtained from the fractionation of human plasma.
This person 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.
What your responsibilities will be
- You will 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.
- You will prepare periodic technical reports.
- You will participate in the preparation/review of validation documentation for computerized systems of laboratory equipment.
- You will provide support to the laboratories in activities related to data integrity.
- You will participate in the deployment of new procedures in the Quality Control laboratories.
- You will work in a GMP environment.
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- You 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.
- At least 2 years of experience in the validation of computerized laboratory systems in a GxP environment will be valued: development of system validation activities and preparation/review of validation documentation (VMP, AR, IQ, OQ, PQ, and other reports).
- You have knowledge of computerized system management: GAMP guidelines, 21 CFR Part 11, GMP Annex 11, etc.
- You have an advanced level of English (First Certificate or higher).
- You have advanced knowledge of MS Office, especially Excel.
- Knowledge of laboratory equipment software (Empower, Tiamo, Endoscan, or similar) will be valued.
- You possess knowledge of SAP or related ERP systems.
What we offer
It is a brilliant opportunity for you, Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.
Information about Grifols is available at www.grifols.com. If you are interested in joining our company and you have what it takes for such an exciting position, then don’t hesitate to apply
We look forward to receiving your application
Grifols is an equal opportunity employer.
Flexibility for U Program: Occasionally remote
Benefits package
Contract of Employment: Permanent position
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