ALK-Abelló A/S

Stability Studies support Chemist

 

 

 

 Stability Studies support Chemist 

The position is focused on non-laboratory support of the QC Stability team leader. Primary activities would generally include but are not limited to

Key Responsibilities

  • Handling stability studies in compliance with internal SOPs and relevant guidelines through execution of the following:
    • Authors protocols and reports to support product stability and use of Sample Manager
    • Data entry and review in the appropriate programs
    • Perform stability data analysis and trending in accordance with SOPs and ICH guidelines.
  • Document writing (change control, out of specifications, deviations, CAPAs), statistical analysis and trending reports, stability data for regulatory filing, stability summaries for product quality review etc
  • Maintain documentation associated with the conduct of a stability study, in accordance with internal procedures and aligned with guidances
  • Participate in inspections
  • Involvement in other QC activities as required

Education

  • Bachelor's Degree in Life  Sciences or equivalent experience with interest and  knowledge  in statistics and data computing
  • At least 2 years of experience in a GMP regulated environment
  • English writing  level advanced or equivalent
  • Considerable knowledge/expertise relevant to Stability Programs, ICH guidelines, QC methods

Other qualifications required

  • Collaborative and positive team player with open and loyal communication
  • Experience  with SAP/ LIMS 
  • Experience with preparing regulatory documentation, writing SOPs, stability protocols and reports as well as annual product performance reports.
  • Excellent English writing skills
  • Self-directed individual who can work with limited direction
  • Expertise in use of Excel or comparable software solutions for management and analysis of data

 

 


We offer

ALK provides a uniquely dynamic and pleasant work environment, complete with inspiring and challenging assignments. The results of your efforts will be significant throughout the organization and you will be able to actively influence and challenge the status quo. Our flat structures attract independent individuals who like to feel the progress of the business and enjoy being close to the decision-making process. You will be part of an engaged and informal global team who values skill and knowledge creation. The job is very flexible and you have very much influence on your daily work. The new position is being a part of a global team, with team members in three countries, but the position will be located in the Madrid office.

Please apply in English.

Contact

For further information on the position, please contact Leticia Garcia Jimenez

LGJES@alk.net

 

 

Compartir en:
Plazo de solicitud:
03/06/2020
Fecha de inicio:
03/06/2020
Provincia:
MADRID
Contactos:
LETICIA GARCIA
Teléfono: +34 913276100
Página web:
http://www.alk.net
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