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SITE MICROBIOLOGIST - SLIGO

 

Job Reference Number

14566496

Client ID:

RI/SJ33449AE

Posted On:

Feb 7 2012

Location:

SLIGO

Job Type:

Permanent

Salary:

NEGOTIABLE

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