Lead or provide technical support for departmental projects, change controls, risk assessments, deviations, CAPAs and audits. Drive and/or coordinate process improvements, utilizing the change control system as required. Generate and analyze trend reports on production processes (both in-process and FIN) and track effectiveness of changes. Support a strong cGMP environment.
1 Provides technical support for departmental projects, change controls, risk assessments, deviations, CAPA's and audits.
2 Provide data/analysis to support groups including: Quality Operations, R&D, Regulatory Affairs, Microbiology, Engineering and Validation.
3 Utilize project management skills to track progress of projects to ensure milestones are met.
4 Stay current on industry trends by reading trade journals, attending trade shows, attending industry training seminars and visiting other pharmaceutical companies.
5 Drive process improvements. Take charge of assigned projects and be able to work with other departments to ensure completion by the deadline set.
Official Reference Copy
McIntyre, Luke D Approved: 15-Dec-2011 5.0
Main Responsibilities and Accountabilities (continued)
Generate an analyze trend reports on production processes and track effectiveness of changes. Communicate this information to department personnel and site management on a routine basis.
7 Coordinates document changes utilizing DCMS.
With a BS/BA in a scientific or technical discipline, 3+ years in a pharmaceutical manufacturing and/or laboratory environment.
With a BS/BA in another discipline, 5+ years in a professional role within a pharmaceutical manufacturing environment.
Competencies Thorough knowledge of Statistical Process Control principles and applications. Solid understanding of cGMP guidelines.
Excellent computer skills and willingness to learn new programs. Effective communication and team-building skills necessary to successfully participate on project teams
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