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Senior Project Manager (QA Microbiology)

Title : Senior Project Manager (QA Microbiology) profile
Sector : Scientific & Laboratory
Location : Cork
Reference : CW121863
Contact : Mike Donovan
Office : Cork Office
Tel : 021-2061901
Email : mdonovan@careerwise.ie

Job Description

A Senior Project Manager is required by CareerWise Recruitment for our Limerick based client. This Senior Project Manager (QA Microbiology) has an opportunity to join a leading multi national pharma/biotech company and will be responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of drug candidates

Role of this position

  • Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
  • Engage directly with site personnel to promote an aseptic operations culture and to provide microbiological subject matter expert knowledge.
  • Provide microbiological support to the internal audit and inspection readiness programmes
  • Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations.
  • Support resolution of problems, identify trends and determine system improvements.
  • The candidate must be familiar with implementation of microbiological environmental monitoring programmes and must understand interpretation of microbiological data including evaluation of trends.
  • Provide microbiological evaluation of site change controls.
  • Support the review and approval of microbial control related documents, including but not limited to, SOPs, validation and qualification documentation, study protocols, and deviation/investigations.

JOB REQUIREMENTS

  • Requires BS degree in Life Sciences or related field
  • At least 8 years of relevant experience, preferably in the pharmaceutical or biotechnology industries.
  • Experience should also include quality control microbiology, critical utilities and involvement with supporting regulatory inspections.

Please call Mike Donovan today for further information on 021-2061901 or email: mdonovan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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Careerwise Recruitment



Senior Project Manager (QA Microbiology)

Title : Senior Project Manager (QA Microbiology) profile
Sector : Scientific & Laboratory
Location : Cork
Reference : CW121863
Contact : Mike Donovan
Office : Cork Office
Tel : 021-2061901
Email : mdonovan@careerwise.ie

Job Description

A Senior Project Manager is required by CareerWise Recruitment for our Limerick based client. This Senior Project Manager (QA Microbiology) has an opportunity to join a leading multi national pharma/biotech company and will be responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialization of drug candidates

Role of this position

  • Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
  • Engage directly with site personnel to promote an aseptic operations culture and to provide microbiological subject matter expert knowledge.
  • Provide microbiological support to the internal audit and inspection readiness programmes
  • Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations.
  • Support resolution of problems, identify trends and determine system improvements.
  • The candidate must be familiar with implementation of microbiological environmental monitoring programmes and must understand interpretation of microbiological data including evaluation of trends.
  • Provide microbiological evaluation of site change controls.
  • Support the review and approval of microbial control related documents, including but not limited to, SOPs, validation and qualification documentation, study protocols, and deviation/investigations.

JOB REQUIREMENTS

  • Requires BS degree in Life Sciences or related field
  • At least 8 years of relevant experience, preferably in the pharmaceutical or biotechnology industries.
  • Experience should also include quality control microbiology, critical utilities and involvement with supporting regulatory inspections.

Please call Mike Donovan today for further information on 021-2061901 or email: mdonovan@careerwise.ie

CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

 

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