Mid-Level
QA Operations Specialist
QA Operations Specialist
Ubicación: Parets del Valles, ES
Tipo de Contrato: Indefinido tiempo completo
Área:
Número de solicitud de puesto: 542541
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, fostering an inclusive environment where diversity makes us outstanding.
Help us lead one of the world’s largest pharmaceutical companies. We are a world leader in plasma-derived medicines with a presence in more than 100 countries, and a growing global team of over 20.000 people. That’s why we need a QA Plasma Operations & Lookback Specialist like you.
The role's mission will be to control and oversee the acceptance process for plasma and non-plasma raw materials, in accordance with established specifications approved for these materials, in order to ensure compliance with legal, regulatory and customer requirements.
What your responsibilities will be
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You will coordinate the surveillance process for plasma units:
- Ensure that the surveillance of plasma units alerted as post-donation information are handled according to the approved procedures.
- Ensure compliance with the established deadlines in the management of alerts.
- Analyze the causes that give rise to communications and inform the Technical Management when the reason requires it.
- Evaluate the potential risk of plasma batches.
- Analyze the data and prepare periodic reports on the process.
- Other administrative tasks related to the plasma surveillance.
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You will control the acceptance process for raw materials:
- Evaluate the supplier documentation associated with the receipt of plasma shipments and plasma fractions against the approved requirements.
- Assess the maintenance of the cold chain during transportation in accordance with the specifications.
- Report and verify the results of the acceptance of plasma materials according to the approved inspection plans, making decisions regarding the use of the associated shipments.
- Manage discrepancies and potential deviations in the process with plasma suppliers.
- Establish and maintain guidelines to be followed in the purchasing and evaluation process of quality-subjected suppliers, advising the coordination carried out by the Purchasing Section.
- Data analysis, filing and administrative tasks related to the raw materials process.
- Coordinate the workflows within the lifecycle of plasma fractions to ensure their availability within the established timelines
- Manage any deviations that occur and collaborate in the investigations that arise.
- Contribute to the necessary tasks for the release of plasma fractions to customers.
- Data analysis, filing, and administrative tasks related to the management process of intermediate products.
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).
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Bachelor's degree in Health Sciences (Pharmacy, Biology, Chemistry), being valuable to have a Master or Postgraduate degree in the pharmaceutical sector.
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You have 3 years of experience within Pharma Quality.
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Knowledge in GMP.
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You have knowledge in Basic Statistics.
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You have knowledge of MS Office and SAP program.
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You have advanced level of English.
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!
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.
Schedule: Monday to Friday from 14h to 22h. (Afternoon shift)
Benefits package
Contract of Employment: Permanent position
Flexibility for U Program: Occasionally remote
Location: Parets del Vallès
Location: SPAIN : España : Parets del Valles:[[cust_building]]
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