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Assist with drafting of process flow diagrams from paper-based master formulas for loading into MES.
Design and assist other designers in the team with filling out predefined templates with data collected from various sources.
Create Compounding Master Batch Records (MBRs) working in collaboration with Pharma Technology specialists.
Create Packaging Generic Master Batch Records (GMBRs) and Parameter Value Lists (PVLs) working in collaboration with QA Documentation specialists.
Support creation and maintenance of Master data, Library elements, EQM State diagrams etc. on an ongoing basis.
Support the creation and management of equipment state diagrams and equipment cleaning/calibration specifications (ESP).
Work with different types of MES PCS - SCADA, DCS and Historian.
Perform when required process measurements and analysis in support of process improvements and to identify core issues (Pareto Chart, Process Flowing Mapping, Time Studies).
Participate in coordinating system design, build, testing and validation for process improvement and GMP related software solutions.
Support testing activities by helping with recipe testing in development environment.
Assist with electronic recipe approvals, preparing and verifying Tractability Matrices between MES MBRs and Paper Master Formulas.
Execute tests and qualification protocols to support implementation of new systems and installations if required.
Provide adequate training to stakeholders pertaining to the implementation and use of MES.
Prepare reports, user and maintenance manuals, procedures, technical specifications, and qualification protocols.
Assist business technicians with shop floor support activities with regards to use of MES if required.
Refine training materials such as SOP’s, training manuals and other documents based on feedback from MES specialists from various departments.
Complete all GMP Documentation correctly and in a timely manner.
Complete all training assignments and maintain personal training records.
Initiate, and follow through with actions required to close Change Controls.
Other duties as assigned.
Designer, MES Recipe
SUN PHARMA
Brampton, ONCAD57K - CAD71K / yearPosted 3 weeks ago
Full-timeonsiteentry