Analytical Method Transfer Chemist

Kenny Whelan And Associates

Little Island , Cork

Kenny-Whelan are recruting an Analytical Chemist for method tranfser at our clients API pharmaceutical site in Little Island. Contact Jenn Dinan on 0214665408 and email CV's to jdinan@kenny-whelan.ie. Analytical Method Transfer Specialist – Quality Control. 2. Job Purpose: • Lead and co-ordinate analytical technical transfer projects to support introduction of new test methods into QC laboratories in Grange Castle. • Liaise with the New Product introduction leads to develop and validate new methods and new equipment as required to support the introduction of new products to the site. • Lead and co-ordinate analytical method transfers to external contract sites, other sites and/or markets as required to support regulatory submissions. Analytical Method Transfer Specialist. Job Responsibilities: Technical. Technical review and critique of analytical method validation reports from external sites and completion of gap assessments as required versus ICH guidelines. Author, review and approve analytical method gap analysis, protocols and reports as required. Execute laboratory testing/execution work as directed by QC supervisor. Provide routine analytical and technical support to contract test labs as part of method transfer activities. Maintain regular communications with external sites as part of method transfer and future state testing activities. Present updates on Analytical method transfer projects as required to internal and external forums as required. Support QC testing teams as required and as directed by QC supervisor. Record and review all analytical documentation to cGMP standard. Oversee the generation of new QC test methods as part of overall method transfer activities. Maintain/complete all assigned training as per curricula without reminder. Implement and adhere to appropriate levels of cGMP. Promote safety awareness and the established culture of IIF within the assigned work area. Work with EHS team to complete assessment of all new materials required in the lab as part of method transfer and/or routine release testing activities. Communicate workload to QC External Support Lead/ QC management via dashboards/other forums as appropriate. Complete documentation associated with analytical results in a timely manner. Report and document any non-conformances to the QC Supervisor. Assist in the preparation and review of area documentation (SOP’s, Reports, Protocols. Ensure training compliance within assigned work area and QC. Perform and assist in additional duties as directed by the QC Supervisor. Core Competencies. Experience in analytical techniques including but not limited to High Performance Liquid Chromatography with Empower, Capillary Electrophoresis, Part Mat, Osmolality, pH, appearance testing, UV, Karl Fischer, SDS Coomassie. Experience with Lab systems an advantage. (LIMS, CDAS, Trackwise, PDOCs. Proven success in proactive project management. Self directed, self motivated with a demonstrated record in project accountability. Proven ability to communicate problems and required resolution in a positive manner to all levels of the organisation. Educational background. Minimum BSc Degree and 5+ years experience in a Biopharmaceutical or Pharmaceutical cGMP-manufacturing environment required, or equivalent. Previous experience in a method transfer role is desirable. All applications are treated with the strictest of confidence. Contactl Jenn on 0214665408 and email your CV to jdinan@kenny-whelan.ie. This job originally appeared on RecruitIreland.com.

2320 days ago