Pharmaceutical Microbiology Specialist

Job Ref: J31357
Sector: Science
Sub-sectors: Biotech/Life Sciences, Pharmaceuticals, Medical Devices
Job Type: Permanent
Date Added: 04 April 2019
  • Hampshire, England, UK Hampshire Hampshire UK PO13 0AU
  • £35,000 per Annum
    ANNUM
  • Mohamed Ismail
  • 01753 585588
SRG https://www.srg.co.uk https://www.srg.co.uk/-/media/srg/logos/srg_web_2018.png

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A new exciting opportunity for a Pharmaceutical Microbiology Specialist to join a well-established organisation in Portsmouth.

As a Pharmaceutical Microbiology Specialist you will be responsible for:

  • To act as subject matter expert on method validation, method development and sterility assurance collaborating with other internal experts in developing policies and procedures, including CAPAs and Change Controls
  • To work in collaboration with the QA Department and other relevant management to identify opportunities for improvement in current systems and address ongoing issues to include conducting process mapping to identify efficiencies within the microbiology department
  • Troubleshooting within the Microbiology Department, identifying problems and providing recommendations in line with regulatory guidance (cGLP, cGMP, FDA USP) to resolve issues, with a particular focus on sterility assurance
  • Oversight of in-depth, complex Microbiology investigations requiring a high level of expertise acting as the central control of such investigations and managing their progress, by applying knowledge of industry standard alongside use of analysis tools such as Ishikawa fishbone diagrams to determine root cause
  • Keep abreast of current technologies and regulatory standards
  • To report to the Business Manager - Microbiology and Quality Manager on compliance with quality procedures for work performed in the microbiology department
  • To assist with client and regulatory audits as required

To be considered for this position you must have:

  • Degree from an accredited institution in Microbiology and training in cGMP / GLP practices required
  • Good understanding of Quality Assurance / cGMP / FDA regulated industry, preferably related to pharmaceutical laboratory and an aseptic environment
  • Experience in sterility assurance and familiarity with aseptic techniques, environmental control and cleanrooms
  • Demonstrated proficient computer skills (i.e. documentation systems, databases and spreadsheets) and knowledge of Microsoft applications.

Other skills required for the role:

  • Excellent oral and written communication ability, including ability to organise and present data on investigations to senior management, regulatory agencies, clients, etc. as required
  • Demonstrated strong analytical and problem-solving skills; ability to solve complex problems and implement solutions or processes
  • Demonstrated experience in the use of process flows, gap assessments and analysis of data to drive improvement
  • Demonstrated strong interpersonal skills and an ability to work both independently and collaboratively at all levels to achieve common goals
  • Strong attention to detail, and an ability to focus on details of execution
  • Demonstrated experience in a variety of microbiological methods (bioburden, bacterial endotoxin, microbial isolation and characterization)
  • Significant knowledge of sterility testing requirements (USP 71, EP 2.6.1)
  • Working knowledge of current Good Laboratory (cGLP) and Good Manufacturing (cGMP) Practices

This is a great opporynity to join a reputable organisation on a permanent basis.

If this sounds like the right opportunity for you please apply online or contact us on the details below if you have any questions.

01753 589 647

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The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
04/05/2019 16:16:32
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