An excellent opportunity for a QA Senior Associate has arisen to join the quality team within a renowned biopharmaceutical multinational. The successful candidate will serve as Quality point of contact for Packaging operations.
This role currently involves a 2 cycle shift, rotating a 16/5 shift pattern.
• Observe and provide real-time Quality oversight and support for Packaging unit operations.
• Participates in Customer complaint investigations.
• Perform Packaging check audits.
• Provide Quality support for triage and investigation of all classes of deviation events
• Review and approval of Deviations and CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Support continuous improvement and Operational Excellence initiatives
Basic Qualifications & Experience:
• University degree required – Engineering or Science related discipline preferred.
• 3 yrs + relevant experience working in the pharmaceutical or biotechnology industry
• Excellent written and verbal communication skills
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• Strong organizational skills, including ability to follow assignments through to completion
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Experience working with combination products or devices in packaging-related or complaint-handling activities
• Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues
• Operational Excellence experience