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Details

Process Development Chemist LR(A006604)


Reference:A006604 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Chemist

Job Title:Process Development Chemist

Reporting to: Senior Process Development Chemist, Technical Services

Job Role and Responsibilities:

  • Act as primary process development contact for the provision of technical support to plant operations, QA, QC, validation, engineering, Loss Prevention, and environmental personnel.
  • Provide technical support and expertise to production during processing. This involves monitoring of key campaign parameters (yield/quality) and taking appropriate action where necessary, performing real time technical assessments, laboratory investigations and determining the path forward when deviations occur.
  • Perform product impact assessments and quality investigations.
  • Participate in process and quality risk assessments
  • Apply statistical process control tools in monitoring the manufacturing process.
  • Identify process improvement opportunities and support the change with laboratory work where appropriate. Generate technical reports and supporting documentation required to progress the initiative through the change control process. Assist in the management of the process validation.
  • Support project management and execution of technology transfer projects for new and existing technologies, processes (API) and methods.
  • Support the validation of new processes
  • Pro-actively work to improve co-operation with the companies Headquarters Process Development group and to maximize the quantity and quality of development work done.
  • Manage and/or support projects and other initiatives, which may be of a technical or non-technical nature.
  • Participate in training of staff so that staff are trained to safely and effectively carry out their roles and responsibilities.
  • Ensure compliance with relevant regulations and standards associated with cGMP including data integrity, ISO 14001, EMAS, Health & Safety Legislation, Environmental Legislation, and also all site standards, policies, and procedures. Support other sections to ensure such compliance also
  • Other issues as directed by your supervisor.


Experience:

  • Minimum of 2 years working in a process support and/or development function in a cGMP environment.
  • Has a broad GMP and technical know-how to handle emerging issues.
  • Familiar with TrackWise or other quality management systems desirable
  • Strong evidence of problem solving skills
  • Knowledge of technology transfer is preferred but not a requirement
  • Good communication skills

Qualifications / Education Required:

  • Education Ph.D level would be preferable.


If you would like further Information you can contact the recruiter directly:

Libby Ryan | Tel: +353 (0) 1 507 9254