Sr. QA Specialist - Biopharma

Sr. QA Specialist - Biopharm

This company is one of the world’s leading biopharmaceutical companies. Through acquisitions and mergers, this company has expanded rapidly in its short history and as a result of this continued growth; a new opportunity within this organisation has arisen for a QA Project Manager.

This position is responsible for monitoring and supporting the quality performance of contract manufacturers, distributors, material suppliers to all applicable standards for GMP and GDP.

This position is responsible for leading, monitoring and supporting the quality performance of European quality systems according GMP & GDP standards.

The individual may be responsible for, but is not limited to:
• Reviewing and approving batch documentation, data, COAs and supporting QP functions
• Supporting batch disposition
• Designing and implementing European quality systems and maintaining quality metrics
• Approving and leading deviations, change controls, CAPA, investigations and nonconformance reviews, etc.
• Leading drug product complaints and support any recall efforts in conjunction with QP
• Conducting external audits independently as lead auditor
• Conducting training, including GMP/ GDP, for European staff
• Implement Technical Quality Agreements, as required
• Support Product Quality Review, as necessary
• Participating in technology transfer, process scale-up, and process improvement projects.
• Leading meetings with external parties and representing the company in a professional manner

Essential:
• Bachelor’s degree in chemistry, biology or a related discipline
• 5 years plus experience working in Quality Assurance, and/or Qualified Person role to support the manufacturing of drugs, biologics, or devices.
• Thorough understanding of quality systems and cGMPs.
• Experience conducting audits as lead auditor
• Interpersonal skills and professional skills to interact with contractors while representing Shire.
• Must be flexible and comfortable in a “start up” environment
• Must be able to prioritize and multitask in a stressful environment.
• Must be able to travel up to 50% (domestic and international)

Desired:
• Quality experience in parenteral biotech manufacturing (aseptic or sterile processing)
• Experience working with a Qualified Person or Responsible Person
• Experience interfacing with regulatory bodies or working on regulatory submissions.