QA Manufacturing Analyst

Location: 

Dublin, IE

Contract Type:  Regular Full-Time
Area:  Quality
Req Id:  496904

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.


QA Manufacturing Analyst is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO). 


Reporting directly to the Quality Assurance Monitoring Supervisor of Grifols Worldwide Operations (GWWO).
This role offers a chance to work in a state-of-the-art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus. 
Reporting directly to the Quality Assurance Monitoring Supervisor of GWWO the role is for an experienced analyst who will perform aseptic sampling and environmental monitoring as part in the establishment of the Environmental Monitoring programme for aseptic manufacture and water systems for the manufacturing operations at GWWO. 

 

What your responsibilities will be

 

  • Act as a delegate for the quality environmental supervisor when required. 
  • Liaise with Validation, Quality Control, Quality Manufacturing Assurance, Maintenance and the Operations team on execution of monitoring protocols. 
  • Provide quality performance information as required
  • Ensure regular Quality interaction with other Departments 
  • Reviewing and support sampling plans for water systems.
  • Routine sampling of Purified Water and Water for Injection. 
  • Assist and participate in qualification of clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required.
  • Lead and/participate in Environmental excursion investigations, deviations, CAPA and change controls and provide Quality support to the manufacturing area.
  • Support the spot check/walk-through process of the lines.
  • Support the annual product quality reviews if required.
  • Training of new Quality personnel where appropriate. 
  • GMP implementation and site-wide Quality Awareness.
  • Liaise with other Department representatives to promote improvements in GMP and Quality standards.
  • Leading and implementing innovation, best practices and solutions for drug product manufacturing in collaboration with Quality teams from the Grifols sister sites.
  • To support sampling plans for Media Fill and Process Validation batches.
  • To support any other additional activities as assigned by the QA manufacturing Monitoring Supervisor or the QA Manufacturing Manager


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).


 
•    Excellent communication skills
•    Self-motivated
•    Good organizational skills
•    Flexibility
•    Cleanroom performing Environmental Monitoring within the aseptic pharmaceutical/medical devices industry. 
•    Deep knowledge and understanding of the aseptic regulatory requirements
•    Minimum of B.Sc Degree or equivalent third level education and at least 2 years’ experience working in an aseptic pharmaceutical/ medical devices industry.    
•    Grade C/D environmental monitoring experience. 
•    Possibility of Grade A/B environmental monitoring experience. 

 

 

What we offer
It’s a brilliant opportunity for someone with the right talents. 
Grifols understands you want a challenging and rewarding career in a critical function such as Corporate Communications. We’ll help you grow professionally.


Information about Grifols is available at www.grifols.com. If you’re interested in joining our company and you have what it takes, then don’t hesitate to apply.
We look forward to receiving your application.

 


 
Grifols is an equal opportunity employer.
 
Benefits Package
Contract of Employment: Permanent position

Shift Work 

 

#LI-DNI

Location: EMEA : Ireland : Dublin:Grange Castle (Dublin) 

 

Learn more about Grifols