This is what you will do:

Responsible, with management support, for providing Quality oversight of Packaging activities including NPI/Qualification for Finished Product Commercial and Clinical product at the College Park facility. Responsible for ensuring that testing, packaging, labelling, storage of Alexion products comply with QMS and all applicable regulations including including cGMP Biopharmaceutical and Medical Device quality standards.

This role ensures effective interaction with other departments and locations regarding GMP document review and finished product release and partnering with major stakeholders such as Operations, QPs, Device Quality, External Quality , NPI, QC, Engineering and Supply Chain to optimise patient supply.

You will be responsible for:

• Perform issuance and review of batch documentation, management of changes, complaints, deviations, and annual product quality reviews related to College Park operations. 
• Support the QP team, in relation to preparation and review of the relevant documentation for QP release.  
• Provide Quality input, oversight and guidance to Alexion deviations and investigations to ensure robust root cause analysis/CAPA definition and timely closure as per Alexion SOPs and QMS. 
• Generation and reporting of quality metrics.  
• Review and approval of functional area documentation (SOPs, PIs , Work Instructions, technical reports and protocols). 
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled. 
• Author, Review and Approval of QAGs. 
• Leading investigtion actions assigned to College Park  from complaints process. 
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
• Support the drive of Quality Culture and support implementation of continuous improvements at College Park.
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You will need to have:

• Bachelor's degree in science, engineering or equivalent QA experience in international pharmaceutical and/or biotech industry with packaging experience a preference  and advantage.
• Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements
• Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment
• Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization
• Strong verbal and written communication skills with well-structured communication and presentation ability. 

Date Posted

Closing Date