#R-205741
uality and Compliance
o Takes a proactive approach to safety, quality and compliance and actively seeks opportunities to prevent adverse events from occurring.
o Contribute to and assist with Corporate, FDA, HPRA and other regulatory bodies during GMP audits.
o Accountable for ensuring that all staff maintains necessary training qualifications and operate in compliance with SOP's and to GMP standards.
o Review manufacturing batch documentation both paper and electronic in a RFT manner to support timely release to support shipping and disposition cycle time (DCT) commitments.
o Support deviation management and investigations at different levels.
• Accountable for Delivering Results by:
o Supporting the shift teams by providing on the floor holiday/ absence cover, problem solving and project support.
o Supporting the creation of short and medium- schedules and being accountable for the on time in full execution against the plan.
o Ensuring that appropriate staff levels and trained resources are available at all times to meet the plan.
o Communicating issues and promptly escalating issues that may jeopardise manufacturing deliverables.
o Using project management principles to lead complex cross functional initiatives.
o Supporting cross functional engineering, Process development and maintenance teams to improve the reliability of existing equipment.
o Recognising positive performance and sharing best practices with other shifts, departments and sites within the network.
o Lead an assigned process area Work Centre Team (WCT) to ensure cross functional alignment on objectives and action plans.
o Leveraging Gemba and PPoF walks to look for opportunities for improvement and recognise positive contributions.
o Leveraging error management and human performance tools to drive improvements in RFT performance and reduce human performance related deviations.
o Leading lean initiatives such as Kaizen events, A3 projects, 5S initiatives and CI ideas to create a culture of continuous improvement.
o Accountable for Communication and Escalation
o Strong communication skills both written and orally with the power to influence at different levels of the organisation.
o Providing manufacturing performance and project updates at various forums to audiences including senior leadership.
o Escalating any issues which cannot be resolved locally in accordance with Amgen's escalation policy.
• Basic Qualifications & Relevant Experience preferred:
o Typically, 2 - 5 years' experience in a GMP environment
o Bachelor's degree in relevant science or engineering related discipline.
o Be a results-oriented person with excellent organizational, communicational and team development skills with an ability to successfully interact with people, create a team environment and generate co-operation.
o Demonstrated ability to deliver to team, site and personal objectives.
o Demonstrated understanding and use of RFT techniques and lean manufacturing concepts.
o Strong ability to lead, challenge and positively influence in an interactive team environment.
o Strong computer skills - knowledge of Electronic Batch Records, PAS-X, Lims, etc.
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