We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Ideally the person will be responsible for one or more of the following activities in QC including microbiological testing, method transfers, sample and data management and equipment maintenance. This role is for an experienced and technically strong associate who will spend 90% of their work day performing testing.
Responsible for:
Environmental Monitoring of Grade 8/9 Cleanrooms
Environmental Monitoring of Grade 5/7 Cleanrooms & Isolators
Reading of Environmental Monitoring Plates
Bioburden testing of water & disinfectants
Writing technical reports
Testing of In Process samples such as Density & pH
Technically strong background in microbiology and aseptic manufacturing
Experience in LIMS, Change Control, Trackwise, SAP and CDOCS an advantage
Flexibility – the EM role often encounters changing priorities on a daily basis
Experience with Regulatory inspectors and interacting with inspectors desirable
Demonstrated ability to work independently and deliver right first time results
Work is guided by objectives of the department or assignment
Follows procedures
Refers to technical standards, principles, theories and precedents as needed
May set project timeframes and priorities based on project objectives and ongoing assignments.
Recognizes and escalates problems
Demonstrated leadership and communication skills
Auditing documentation and operation process
Demonstrated ability to interact with regulatory agencies
Education and Skills:
Bachelors degree in a science discipline with 2+ years of experience in the pharma or biopharma industry.
Biopharmaceutical QC experience in a microbiology lab
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Experience working in an aseptic cleanroom performing Environmental Monitoring
Proficient in the use of LIMS & LMES
If interested in this posting please feel free to contact Avishek Singh at avishek.singh@lifescience.ie for further information.
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