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Details
Senior QC Microbiology
| Reference: | AS35231 | Location: |
Dublin |
| Qualification: | Degree | Experience: | See description |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
Microbiologist, Microbiology Analyst
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
- Water sampling
- 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
- Problem solving skills
- Experience with Regulatory inspectors and interacting with inspectors desirable
- Demonstrated ability to work independently and deliver right first time results
- Works under minimal direction
- 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 3+ 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 [email protected] further information.
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