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Operate as part of self-directed work team in allocating testing and assigning tasks based on priorities, including daily, weekly, monthly and quarterly tasks. Perform tasks with a high degree of precision and accuracy and ensure others do likewise.
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Liaise effectively with external groups such as Manufacturing, Tech Ops, CQV, Plant Engineering and QA to ensure laboratory support is available as required and testing timelines are met.
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Ensure adherence to lab testing schedules, applying Lean Lab methodology.
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Ensures testing/data review are supported and that results are available within lead times to laboratory customers. Anticipated delays should be escalated, with proposed solutions for resolution.
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Ensures projects are supported and completed as per project timelines. Anticipated delays should be escalated, with proposed solutions for resolution.
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Author/provide leadership in the Laboratory/Contamination investigations using own initiative and with minimum supervision.
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Coach and mentor the Laboratory Team.
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Work as directed by according to Company safety policies, cGMP and cGLP.
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Facilitate and drive effective communication to ensure success.
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Ensure the Lab Tier/handovers are facilitated, and attendance expectations are met.
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Provide support with audit/inspection requirements to ensure department compliance/readiness.
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Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
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Development and execution of Microbiology test methods, Method Validation and Method Qualification.
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Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
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Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
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Ensure that the customer gets the best possible service by continually reviewing best practice in relation to both commercial and quality issues and ensuring 100% ethical work standards and GMP compliance.
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At least 6 years’ experience in an GMP environment, preferably within QC microbiology department.
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Strong knowledge in microbiology related lab test method methods e.g. Environmental Monitoring, Microbial Identifications, Bioburden testing, Endotoxin testing, Biological Indicator Testing, Absence of Contamination Testing (BacT), Growth Promotion/Sterility Testing.
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Experience with New Product Introduction and Microbiology Method Validation experience.
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Deep understanding of data integrity and the importance of adopting this guidance when reporting results / everyday work.
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Is proficient in the use of numerous laboratory instruments, software packages and other analytical techniques.
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Is proficient in problem solving and may have expertise in troubleshooting laboratory equipment.
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Thorough understanding of requirements for working in a GMP environment.
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Ability to quickly learn new processes.
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Ability to communicate clearly and to form strong working relationships with colleagues.
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Ability to work on own initiative and be capable of developing solutions to problems as part of a team.
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Willing to operate in a flexible manner and be able to switch priorities at short notice.
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Good team player, organised, accurate, have strong documentation skills.
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Passionate about quality and customer service.
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Good communication skills both internally and externally and avoids making mistakes that will hinder the understanding of his/her written and verbal exchanges.