To provide process and technical support to the Manufacturing Operations teams to enable Value Stream to deliver its operational objectives. Areas of support includes process optimization, validation activities, continous improvement, change management, deviation investigation and production project management to ensure that Value Stream can operate optimally and in compliance with cGMP requirements.
Responsibilities
1. Operations
a) To support Manufacturing Operations in the following areas:
Manage deviation investigations and CAPAs of high complexity and related to process or technical events.
Changes including eCCs, SMRs and SAP master data (e.g. BOM)
Non-process specific training
Key participant in the Quality Review Board and be able to explain trends
Support Manufacturing Operations in tracking process parameters
Quality and business-continuity risks
Gap analysis against QMS (CQMPs, GGs) and Quality Alerts
prepare documents and training materials as required to support the activities of the operations department
b) Identify, manage and execute improvement initiatives in the following areas:
Batch records/SOPs
Process optimization
Alarms management
Materials management
Operational Excellence (OE) initiatives
c) Support Manufacturing Operations in executing validation, trials, development and technical transfer activities where necessary
2. Interface
Develop relationship within Value Stream team and with other departments (including MSAT, QA, QC TS etc) to ensure delivery of operational objectives
3. Management/ Leadership
Plan, manage and execute deliverable through proper and timely request and utilization of resources to ensure delivery of tasks and projects
Plan and coordinate effective utilization of ad-hoc team members (Manufacturing Operations Staff)
4. Technology Transfer
Participate in new technology and/or new process transfer
Knowledge, Skills & Experience
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