Search Results: 10 vacancies
£41.2k - £44.6k per annum
...procedures.
* Responsible for the identification and communication of adverse trends in routine microbiological monitoring
* Oversee sterilization testing and testing to support manufacturing and new product development.
* Consult on quality and microbiological issues,...
£30k - £42.9k per annum
...manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.
* Lab experience within industry - Bioburden / Endotoxin / Growth Promotion / Environmental Monitoring.
* Experience within a sterile cleanroom environment
...manipulation together with experience within a GLP/GMP environment and knowledge of current EU/FDA/ICH/HPRA guidelines.
* Lab experience within industry - Bioburden / Endotoxin / Growth Promotion / Environmental Monitoring.
* Experience within a sterile cleanroom environment
...adherence to specifications.
Running of high-speed aseptic Filling lines – Isolator technology.
Aseptic assembly of Single Use Aseptic sterile systems.
Set-up of Sterile Filtration systems – pre & post filter integrity testing
Complete Visual Inspection on Finished...
...~3rd level qualification in a Science/Engineering or related discipline and/or minimum 2 years GMP experience, preferably Aseptic/Sterile Manufacturing
~ Knowledge of working within a cGMP environment.
~ Experience working with SAP within a similar industry is preferable...
...and stability testing such as: Environmental Monitoring, Water sampling, Bioburden, Endotoxin, Growth promotion, In-process testing, Sterility testing, APET and Antibiotic Assay.
Report writing.
Draft and review documentation –SOPs, protocols, training modules,...
...Third Level Degree in a Science, Quality or Engineering discipline.
• 2-3 Years of QA or Microbiology (Environmental Monitoring, Sterility) experience in a GMP Environment with experience in support of Aseptic Manufacturing ideally
• Strong knowledge of Regulatory Requirements...
...of 4 years’ experience in an aseptic manufacturing environment.
Experience in aseptic techniques, formulation, aseptic filling of sterile products, and/or visual inspection of Parenteral products.
Detailed knowledge of cGMP and regulatory requirements in the pharmaceutical...
...years’ experience in aseptic manufacturing environment.
* Must have experience in aseptic techniques, formulation, aseptic filling of sterile product and/or visual inspection of Parenteral products.
* Detailed knowledge of cGMP and regulatory requirements relating to the...
...their life cycle
Proficient in using statistical analysis for analysing data and trends
Previous experience of Gamma and EO Sterilization methods and experience of conducting validation for same would be an advantage
Participate in preparation for annual Management...