Search Results: 7 vacancies
...~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...
...required
~ Completion of quality records in QMS
~ Implementation of product dedicated controls for the Core 1 area.
~ Performing sterile filtration and filter integrity testing.
~ Supporting regulatory inspections as required
~
Qualifications
So, what...
...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...
...stages of lifecycle including clinical, non-clinical and pre-clinical material.
Batch preparation activities (vial washing, load sterilization, area preparation).
Work aseptically or as required by the classification of the production area(s)
Perform compounding,...
...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...
Recruit Island
Castlebar, Co. Mayo
2 days ago
