Main responsibilities:

• Reviewing validation documentation and additional protocols and reports
• Checking GMP documents and raw data for compliance to applicable regulatory and corporate guidance documents, such as CAPA´s, deviations, operational procedures
• Approval of change control documents and activities associated with change control implementation
• Keep up to date on CGMPs and regulatory requirements as well as global procedures, guidelines and policies.
• Proactively identify and propose resolution to both technical and compliance issues/gaps, as well as development and implementation of Quality Systems.

• Minimum 3 years experience in the Biotech or Pharmaceutical industry 
• Experienced with GMP documentation
• Good knowledge of compliance and regulatory requirements 
• English is a must, any additional language is a plus

Soft Skills:

• Team player
• Growth mindset
• Excellent communication skills

Education:

Bachelor or Master Degree in the field of Physical or Biological Science or Engineering. 

The Sr. Associate for QA will be responsible for supporting our quality management system on review and approval of validation and engineering documents, test protocols, CAPAs, deviations, change controls and various technical documentation. The QA needs approval before implementation and upon completion. Furthermore advice the project groups as appropriate and be an active member of the groups where the quality input is needed.

This is a great opportunity to join a dynamic team and work on complex projects. The Biogen Elements reflect an ethical, inclusive, agile, pioneering, customer focus and accountable workplace for every individual.