About this role
How You Will Achieve It
Support the Process Engineers in the preparation of documentation required to launch a product campaign .Monitor and maintain the plant documentation on a proactive basis, whilst continually reviewing the systems and procedures to identify areas for improvement. These documents include, but not limited to Recipe Change controls, Manufacturing Instructions, Record of Manual Operations, Documents related to cleaning, Change controls.Co-ordinate the overall administration of the plant documentation in close liaison with the Operations Supervisor, Process and Operations Manager and the shift teams.Batch record review for compliance to Good Documentation Practices.Responsible as department document co-ordinator to issue and reconciled controlled copies of the operating and cleaning instructions, log books and any other documents to operations team.Conduct day to day review of forms and documents to ensure Good Documentation Practice. Perform reconciliation on the forms and documents upon completion.Ensure all documents are in completion and perform archival as necessary.Coordinate with EHS and Warehouse team on waste disposal information pertaining to waste generated during operation.Follow up CAPA actions when necessary.Report all actual, near misses and potential accidents for further investigation when needed.Raise purchase requisition for plant use and equipment relevant items when necessary.Review and revise relevant Standard Operating Procedure when necessary.Assist Day Lead Technician in terms of documentation related tasks when necessary.Assist Day Supervisor in any documentation tasks when necessary.Develop courses of action and drive implementation of solutions.Uphold Pfizer’s code of conduct and values.Accountable for:
Monitoring & Completion of Plant DocumentationPlant Documentation PreparationPlant AdministrationTrend Reporting & AnalysisDocumentation preparednessPlant reports on scheduleMetric measurement reports Qualifications
Must-Have
Nitec or Diploma in a technical discipline3 years experience in a cGMP manufacturing environment
Nice-to-Have
Process & Plant KnowledgeStrong IT and reporting skillscGMP and GDP KnowledgePersonal & Organization Skills All your information will be kept confidential according to EEO guidelines.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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