Job Description: Performs, coordinates, and exercises functional authority for planning, organization, control, integration, and completion of continuous improvement tasks within area of assigned responsibility. Use project management, lean manufacturing, and six sigma tools to achieve cost reduction results per the strategic plan on every budget process. Coordinates improvement activities with plant schedule and resources within the assigned manufacturing area.
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Prepare weekly and monthly OPEX scorecards to Value Stream Leaders.
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Plan and lead or facilitate kaizen events when required.
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Champion, coach, and mentor systematic problem solving using DMAIC and A3.
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Perform Total Loss Analysis, TEEP, and OEE analysis as required.
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Integrate continuous improvement efforts with VIP.
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Active participation on budget cycle updating, cost impact and QLP process.
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Develops, implements systems or projects, procedures and policies to ensure compliance with cGMPs, Safety and FDA regulations.
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Creates, reviews and implements changes to specifications and SOPs.
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Audits all areas under responsibility ensuring the compliance, cGDPs, specifications, SOPs, and procedures.
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Supports and assists in the troubleshooting of projects and equipment as required. Also assists validations process.
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Completes all documentation and reports on a timely basis as required (daily, weekly, monthly and annually).
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Communication and Training
o Support the training program, including the periodic qualifications of pharmacy employees
o Regularly communicates with all site staff regarding quality issues and promotes the quality system as a business process for improvement of customer satisfaction and regulatory compliance
1. Document and Data Management
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Own and approve local documentation, as required.
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Ensures all procedures are controlled and current versions are available to staff as required
2. Sterility Assurance
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Support the Environmental Monitoring and Sterility Assurance program for cleanrooms and ensure compliance with applicable requirements
3. Quality System Measurement and Review
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Support of the CAPA system using Track wise software
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Support of complaints using TW8
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Support adverse events to Pharmacovigilance and the Business management representative
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Support local change control process to ensure all changes are fully documented
4. Validation
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Support the management and schedule of the site Validation Master Plan
5. GMP and Facilities and Equipment Control
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Ensuring all measuring equipment that may have an impact on product quality are calibrated to traceable standards
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Ensuring site:wide local systems are in compliance with Baxter Corporate and Regulatory / GMP requirements / EHS
6. Audit Management
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Support the audit process for the facility, organization of the management team and staff to ensure a successful audit
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Able to work with minimum supervision.
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Able to work with many projects and handle multiple tasks at the same time.
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Must be able to communicate effectively at all Plant Levels.
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Willing to travel.
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Willing to work extra hours, any shift or Holidays (eg. shutdowns, extraordinary events).
Requirements:
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Bachelors degree (B.S.) in Engineering (Industrial preferred); computer knowledge.
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Six Sigma Green Belt certification or equivalent experience and Minimum of 1:3 years' experience using lean:six sigma continuous improvement methodologies in a manufacturing e
