Job Description

12,000! That\xe2\x80\x99s the number of our Global Drug Development (GDD) associates we empower to deliver value to patients through our development of products and programs that create knowledge, deliver learning and build applied skills. We have high ambitions to transform the way we help people learn, and we\xe2\x80\x99re building a Capability team who have the imagination, grit and expertise to make that a reality, fast.

Your key responsibilities:
Your responsibilities include, but not limited to:

• Support the timely release of GMP relevant documents and batches. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP in TRD.
• Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
• Write and review GMP-relevant deliverables and or/ related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
• Support project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
• Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidances, SOPs etc.)
• Approval of GMP relevant documents (as specified below) and decision making according to applicable processes. Review and Approval of executed analytical batch documentation records including attachments. Review and Approval of Analytical specifications (GLIMS)
• Manages projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards