Quality Assurance Specialist
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 *Quality Assurance Specialist* to join Quality Assurance area 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.
What your responsibilities will be
- Monitor the Data Integrity review plan in laboratory and production areas.
- Evaluate electronic records and critical data, ensuring their integrity (ALCOA\+).
- Participate in the identification of regulatory gaps regarding system data integrity and their assessment. Identify deviations and propose corrective and preventive actions (CAPAs).
- Prepare compliance reports and action plans.
- Collaborate in internal and external audits.
- Review IT system validation documentation (URS, FS, DS, IQ/OQ/PQ), ensuring compliance with GxP regulations and computerized system validation guidelines. Identify gaps and participate in their remediation.
- Review technical reports and software specifications, ensuring that systems meet Data Integrity requirements.Participate in digital transformation initiatives in laboratory and production related to Data Integrity compliance.
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).
- Bachelor’s degree in Life Science field (Biology, Chemical, Engineering, etc).
- Minimum 3 to 4 years of experience in a similar position within pharma sector.
- You have high knowledge in GMP.
- You have knowledge of Data Integrity and computerized system validation.
- You have experience in reviewing technical and regulatory documentation.
- You have knowledge of GMP, GAMP5, FDA 21 CFR Part 11, EU Annex 11 regulations.
- You have knowledge of computerized systems in laboratory and production (LIMS, MES, ERP, BR).
- English: Advanced level.
- You have excellent communication skills.
- You have the ability to analyze in an agile and decisive way.
- You are able to expose the issues in a clear and organized way focused on the objective.
- You have the ability to work as part of a team.
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!
We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.
Grifols is an equal opportunity employer.
Flexibility for U Program: Hybrid
Flexible schedule: Monday\-Thursday 7\-10 to 16\-19h and Friday 8\-15h (with the same flexibility start time).
Benefits Package
Contract of Employment: Permanent position
Location: SPAIN : España : Parets del Valles:\[\[cust\_building]]
Learn more about Grifols
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