QC Associate Microbiology Specialist.

We are actively recruiting for a QC Microbiology Specialist to provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products within a leading Pharmaceutical Manufacturing multinational.

Key Responsibilities:

• Development and execution of Microbiology test methods and project validations.
  
  
• Troubleshooting of issues which arise during the execution of validation studies and routine tests.
  
  
• Development of training modules.
  
  
• Microbiology Support to Site Investigations
  
  
• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
  
  
• Authoring and managing change controls, procedures, test methods and deviations.
  
  
• Result authorization for microbiological samples to support batch release.
  
  
• LIMS System updates
  
  
• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.
  
  
• Supporting lab stock management and financial control as required.
  
  
• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
  
  Qualifications and Experience
  
  
• Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
  
  
• Demonstrated change management skills (CEM) with continuous improvement.
  
  
• Strong knowledge in execution, validation and development of microbiology related test methods i.e. Bioburden, Endotoxin and Sterility testing.
  
  
• At least 5 years’ experience in the Microbiology Pharmaceutical industry or a similar operating environment
  
  
• Strong Planning and Organising skills
  
  
• In-depth knowledge of the veterinary market
  
  
• In depth knowledge of pharmacovigilance legislation and guidelines
  
  
• Wide-ranging and sound communication skills
  
  For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)