Top 3 Must Have Skill Sets:
Experience working in cGMP production environments including direct support with cGMP manufacturing processes (production and quality background).
Understanding and proven real-life application of regulations in a cGMP Environment.
Strong interpersonal skills; comfortable communicating with both internal team and external clients.
CONTRIBUTE TO THE MATURITY LEVEL AT SUPPLIERS
Ensure successful execution of cGMP compliant manufacturing activities at supplier’s location according to knowledge of agency expectations and compliance with applicable regulations.
Represent in manufacturing operations at the supplier’s facility to ensure error-proof production activities.
Review production readiness; identify improvement opportunities and remove roadblocks; engage key staff as appropriate.
Confirm that the supplier’s supply chain task execution is in alignment with expectations.
Confirm supplier’s material management readiness.
Contribute to the implementation of meaningful metrics to track adherence to plan and overall health of the program.
MONITOR AND IMPROVE THE SUPPLIER PERFORMANCE AND RISK SURVEILLANCE
Build a good understanding of supplier’s raw materials, molding, assembly and processing equipment.
Proactively engage in the production steps to obtain working knowledge of floor challenges.
Assess risk by the active collection of feedback on supplier’s performance; input to be incorporated into supplier oversight practices.
Align supplier’s production schedule to forecast; identify and help to resolve roadblocks and supply issues.
Communicate issues/updates/decisions on key deliverables and activities to throughout the manufacturing process (including pre and post); consistently engage core team members/Management.
Prior to any run - evaluate site production readiness.
Post run/stage/operation – evaluate supplier’s performance and identify weak signals/areas for improvement.
ENHANCE CROSS COMPANY COMMUNICATION & RELATIONSHIP
Ensure immediate assistance and communication to in case of any unexpected event.
Support triage of investigations and/or deviations to ensure communication and acceptable mitigation strategies per requirements.
Provide updates/summary reports of supplier’s performance, related to checklist, to the team at a minimum of weekly (past highlights/lowlights, forward looking).
Be present at supplier’s facility to observe unit operations and review documentation as deemed necessary.
During the run – be engaged in production progress and with identifying early warning signs; suggest corrective actions real-time.
Provide real-time production updates to other colleagues as requested.
"This posting is for Contingent Worker, not an FTE"