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PHARMACEUTICAL MICROBIOLOGIST - UP TO £46K - WILTSHIRE

PHARMACEUTICAL MICROBIOLOGIST - UP TO £46K - WILTSHIRE

Posted 23 April by Bosch Global Associates Ltd Easy Apply Ended

JOB SUMMARY

To lead and manage QC staff engaged in EM to plan and manage resources so that EM and testing meets regulatory requirements. Provide advice and recommend actions to manufacturing units for the resolution of microbiological OOS, adverse trends and discrepancies. Review aseptic practices and EM in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements.

MAIN DUTIES AND RESPONSIBILITIES

  • To play a lead role in the review of environmental monitoring data as part of the Environmental Monitoring (EM) management team.
  • To lead and manage QC staff engaged in EM to plan and manage resources so that EM and testing meets regulatory requirements.
  • Provide advice and recommend actions to manufacturing units for the resolution of microbiological OOS, adverse trends and discrepancies.
  • Review EM, process simulation and non-conformance data for adverse trends in liaison with the EMT and initiate action accordingly.
  • Review aseptic practices in manufacturing facilities to ensure the approach taken is in line with industry best practice and meets regulatory requirements.
  • Advise PBL management of any risks that may impact the ability of PBL to operate to GMP.
  • To provide specialist microbiology training within Biological Services, and also to personnel involved in GMP manufacturing activities.
  • To maintain up to date awareness of regulatory and scientific advances by attending training courses and meetings that contribute to the efficiency and effectiveness of staff training and working practices.
  • To suggest and implement improvements to work practices/procedures within the framework of regulations.

REQUIREMENTS

  • Educated to a degree level in a relevant subject

KNOWLEDGE AND EXPERIENCE

  • Experience of working to cGMP in a pharmaceutical QC or Production environment
  • Knowledge and experience of microbiological environmental monitoring, microbiological testing methods (including pharmaceutical water systems, microbial identification and aseptic manufacture)
  • Experience of management of a small team
  • Experience of working within a GMP quality system
  • Experience of biopharmaceuticals (desirable)

KEYWORDS

PORTON DOWN / WILTSHIRE / SALISBURY / BIOLOGICAL SCIENCE / CHEMISTRY / PHARMACEUTICAL / DEVELOPMENT / EQUIPTMENT / PHARMACEUTICAL PRODUCTION / PROCESS DEVELOPMENT / ANALYTICAL DEVELOPMENT / QUALITY CONTROL / QUALITY ASSURANCE / GMP / SUPERVISOR / ICH GUIDELINES / SOFTWARE / cGMPs / METHODS / ESSAYS / TECHNIQUES / SYSTEMS / TECHNOLOGIES / PBL / INDETIFYING / MICROBIOLOGY / MICRO-ORGANISMS / BIOPHARMACEUTICALS / ASEPTIC / MANUFACTURE / ENVIRONMENTAL / MANAGEMENT / WATER SYSTEMS / MONITORING / SCIENTIFIC / TESTING / OOS /

Reference: 31898114

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