Manufacturing Quality Project Manager - JIJ-726

Manufacturing Quality Project Manager - JIJ-726

17 abr
|
Grifols
|
San Cugat del Vallés

17 abr

Grifols

San Cugat del Vallés

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Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.



Help us lead one of the world’s largest pharmaceutical companies!



The Manufacturing Quality Project Manager,

will be responsible for providing support to Quality Project Director in those aspects related to the Manufacturing plant design and development and for defining Quality System and specifications that manages all the processes related to the manufacturing of plasma derived products.



What your responsibilities will be



You will have the opportunity to:



- Establish Quality structure in manufacturing plant in order to assure the compliance of all products manufactured with licenses approved at Health Authorities level, ensuring the quality and security of final product, in accordance to cGMP, 21CFR FDA Requirements and in accordance to European Regulations (European Pharmacopeia and EMA regulation)

- Implement SOP’s that will manage all the procedures related to plasma-derived products manufacturing, including final products and intermediates products Quality Control.

- Coordinate and update the Department's Documentary System.

- Establish KPI in order to control the evolvement of Quality system along the Supply chain.

- Ensure that Quality Policies to be implemented are according to Quality Polices established in Grifols.

- Perform audits in plasma centers, plasma testing laboratories and plasma storage and transportation processes when it’s required.

- Maintain updated the Technical Information related in order to have in force licenses approved at Health Authorities level

- Review internal and corporate audits performed, and Regulatory inspections received from the Health Competent Authorities, and evaluate Corrective and Preventive actions taken as result of them.

- Carry out quarterly and annual reports.



Who you are



- You have a scientific degree in pharmaceutical or biomedical area.

- You have knowledge of 21CFRFDA Regulation, European Pharmacopeia (Human Plasma for fractionation), EMA regulation.

- You have been working at least three years in a similar position, preferably in a pharmaceutical and multinational context, in environments of Good Practice Auditing (GxPs)

- You have knowledge in Good distribution Practices (GDP’s).

- You speak fluent Spanish and English.

- You have availability to travel up to 30% of the time to Egypt.

- You are communicative, proactive and analytical.



What we offer



- Permanent position. 



This 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. 



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.

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