SITE MICROBIOLOGIST - SLIGO
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Job Reference Number |
14566496 |
Client ID: |
RI/SJ33449AE |
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Posted On: |
Feb 7 2012 |
Location: |
SLIGO |
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Job Type: |
Permanent
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Salary: |
NEGOTIABLE |
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Our client, a pharmaceutical company in Sligo, is seeking to recruit a Site Microbiologist to join their team.
Description:
- Provide microbiological support to the site, ensuring facility and process sterility programme compliance to in-house, corporate and regulatory requirements.
Key Responsibilities:
- Monitor and control the microbial aspects of the Quality System at the Site.
- Operational microbiological support of environmental monitoring, facility / equipment cleaning and clean utilities.
- Microbiology related technical support for manufacturing activities, e.g. aseptic technique development.
- Development of microbiological requirements and methods for cleaning, sterilisation, filtration, facility and personnel monitoring etc.
- Review and develop current procedures for all microbial activities
- Develop and implement training programme for all microbial activities.
- Oversight of facility environmental monitoring programme.
- Responsible for sterility assurance aspects of all GMP inspections / audits from global and regulatory bodies.
- Assist in microbiological aspects of internal and external audits as required.
- Assist in microbiological aspects of investigations, change controls , annual product reviews.
- Maintain compliance to cGMP regulations.
- Complete duties in compliances with the Company’s Environmental Health and Safety procedures.
- Foster a good working relationship with all departments and uphold the company's Values of Integrity, Excellence and Respect for People.
- Comply with the Company’s HR Policies and Code of Business Conduct.
Competencies:
- Technical / Professional Knowledge - Having achieved a satisfactory level of technical and professional skill or knowledge in position related areas, keep up with current developments and trends in areas of expertise.
- Continuous Learning – Actively identify new areas for learning and take advantage of all learning opportunities. Apply new knowledge and skills gained in daily activities and learn through their application.
- Planning and Organizing - Establish courses of action for self and others to ensure that work is completed efficiently.
- Safety Awareness – At all times be aware of conditions that affect employee and product safety.
- Work Standards - Set high standards of performance for self and others; assume responsibility and accountability for successfully completing assignments or tasks and self impose standards of excellence rather than having standards imposed.
Experience and Knowledge:
Essential
- Degree (Hons) qualified in microbiology
- 3/5 years post qualification experience in industry ideally in a similar role.
- Experience in FMEA and QRM
- Experience in IMB/FDA audit participation
- Ability to co-operate and work well with others in the pursuit of team goals
Desired
- Experience in fermentation technology
- Cleaning validation experience
- Mammalian cell culture experience
- Sterile filling experience
- Autoclave validation experience
For further information please contact Aideen Cummins on 071 9142411 or email aideen.cummins@collinsmcnicholas.ie