- C&Q of Process Equipment - Sterile Manufacture and HVAC set up
- Pharmaceutical project located in the Inner Suburbs of Brisbane
- 6 + month contracts (possible extension)
Our client is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, servicing the pharmaceutical, medical device, biotechnology and animal health industries
With offices located worldwide, they offer a comprehensive service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, creating solutions that are proven to be a winning combination for global corporations, as well as small and medium sized companies.
We are seeking Cleanroom / Manufacturing Experts to work on a 6 + month projects, with extensive experience in commissioning and qualification of manufacturing /process equipment for a pharmaceutical company located in the inner suburbs of Brisbane.
The successful candidate will possess the following skills and key criteria:
- +3 years of experience
- Experience and in-depth understanding of all system lifecycle deliverable from Commissioning and Qualification (C&Q).
- Extensive experience on Commissioning & Qualification of Process Equipment- Manufacturing Systems (Vaccine)
- Extensive experience on Equipment Life Cycle Activities: Requirement Specifications, Procurement, Impact Assessment, Risk Assessment, Validation Plans, URS, Procurement, DR/DQ, Commissioning (FAT/SAT), IQ, OQ, PQ, RTM, Periodic Review, Decommissioning.
- Knowledge of C&Q Document Preparation activities for their Functional Area. This will include Risk Assessments (SRA) / Design Qualification (DQ) Reports / System Start-Up (SSU) Test Packs / System Test Protocols (STPs) / System Acceptance and Release Reports (SARR) - per the C&Q schedule.
- HVAC Commissioning and Qualification for Sterile Injectable Facilities as well as non-Sterile facilities per ISPE, ISO-14644, WHO, USFDA, EU-GMP Guides.
- Facility Qualification.
- Experience on smoke studies on Cleanrooms.
- UDAF/ Laminar airflow, Bio safety cabinet and Dynamic pass box Qualification.
- Provide technical support and guidance to clients and other project team members in protocol preparation, execution and data interpretation.
- Strong handling of protocol deviations with detailed insights of deviation descriptions, root causes, investigation, remediation with corrective and preventive actions and final closure with the approvals from QA.
- Generate deviations, root cause analysis, and assist with deviation investigations.
- Pre-execution and post-execution revision and approval of protocols and Summary Reports.
- Possess strong technical writing and communication skills.
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on 0437 853 201.