Your new company

Your new role

• Quality Oversight for new product introduction in a Bulk Drug Substance facility.
• Quality oversight for new or modified facilities, equipment, technologies, including analytical, as well as other continuous improvements and reclassifications.
• Site QA responsibility is to provide technical expertise for all QA and compliance topics / issues relating to the Alexion manufacturing Facility.
• Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, Equipment and others.
• Review and approval of qualification/verification/validation documents for facilities, equipment, processes, analytical methods, suppliers, software and others. (e.g. URS, Facility, Utility, IT Systems, Test Methods, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.

What you'll need to succeed

• A minimum of 6–8 years relevant experience within the pharma industry or a related field.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.

• Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes is strongly desirable.

• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing.
  
  
• Excellent accuracy and attention to detail

What you'll get in return

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.