Senior Validation Specialist
6 days ago
About the Role:
We are seeking a highly skilled Senior Validation Specialist to join our team at SitePoint Pty. As a key member of our Quality Assurance team, you will be responsible for providing quality oversight to support the implementation and maintenance of strategic computerised systems.
Key Responsibilities:
- Fulfil the Quality Assurance responsibilities in the preparation and approval of Computer System validation records or manage the process in accordance with relevant procedures.
- Provide input to the validation planning of high cost, complex, strategic systems using risk-based approaches to ensure systems are fit for purpose.
- Provide and/or facilitate quality assurance oversight for the automation of business processes related to pharmaceutical manufacture, laboratory and distribution.
- Identify, resolve, and avoid project problems, typically involving ongoing interaction with management teams within Tech functions, Site and Local Operating Company Quality organizations, and Third Party suppliers/service providers.
- Participate in the deployment, maintenance, and inspection support of multiple global projects with responsibility for developing solutions that maintain compliance and keep validation on schedule and within budget.
Requirements:
- Bachelor's degree or equivalent industry experience/subject matter expertise.
- Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations.
- Broad experience in independently providing validation, deployment, change management, and inspection support of large, complex, computerised systems.
- Demonstrated ability to interpret and apply company guidelines, principles and expectations such that systems are validated in proportion to the risk they present to patient safety and product quality.
- Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerised systems.
- Demonstrated ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation.
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