Senior Validation Specialist

4 weeks ago


London, Greater London, United Kingdom SitePoint Pty Full time

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:

  1. Fulfil the Quality Assurance responsibilities in the preparation and approval of Computer System validation records or manage the process in accordance with relevant procedures.
  2. Provide input to the validation planning of high cost, complex, strategic systems using risk-based approaches to ensure systems are fit for purpose.
  3. Provide and/or facilitate quality assurance oversight for the automation of business processes related to pharmaceutical manufacture, laboratory and distribution.
  4. 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.
  5. 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:

  1. Bachelor's degree or equivalent industry experience/subject matter expertise.
  2. Understanding of pharmaceutical manufacturing and distribution regulations, guidelines, principles and expectations.
  3. Broad experience in independently providing validation, deployment, change management, and inspection support of large, complex, computerised systems.
  4. 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.
  5. Technical knowledge to support quality and validation decision making for GxP analytical, manufacturing, distribution and IT computerised systems.
  6. Demonstrated ability to successfully manage support to regulatory inspections including specific queries of computer systems validation/compliance activities and documentation.


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