* Global pharmaceutical manufacturing organization
* They are seeking to appoint a Senior Validation Engineer to join their team on a 7-month contract with potential for extension
* Based in Northern Suburbs
About the company:
* Global pharmaceutical manufacturing organization
* Monday - Friday, standard working hours
* Based in Northern Suburbs
Duties:
* Autonomously lead and perform validation projects associated with changes to existing processes/materials, new processes/materials and projects
* Assist in development of Project Validation Plans
* Contribution to the control/supervision of validation action plans
* Evaluation and review of validation data, management of change controls and deviations in projects
* Perform validation activities in accordance with the Quality Management System, Site Validation Master Plan and Validation procedures
* Approve validation related documents (risk analyses, protocols, reports) when requested
* Assist in investigations for validation deviations (root cause analyses, impact analyses, CAPA definitions)
* Participate in change control panels and perform assessment of change controls for impact on validation status when requested
* Perform a Quality assurance GMP review / approval of qualification related documents (qualification and requalification protocols, reports)
About you:
* Tertiary qualification in science or engineering
* At least 5 years’ experience in the pharmaceutical manufacturing industry with experience in Process and/or Cleaning Validation
* Strong knowledge of cGMP including current knowledge of industry guidance documents and standards focusing on validation principles and applications relevant to process and cleaning validation
* Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks.
* Computer literacy and experience using Microsoft applications and familiarity with eQMS, LIMS (e.g. Sample Manager), JAG, SAP, statistical software.
* Sound problem solving and negotiation skills.
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Sarah or Cathy on 03 9040 1630. #J-18808-Ljbffr