Represent CSQA and participate in the review and approval of computer system documentation throughout the lifecycle of an application.
Review and approval of change requests through to closure of computerized systems and infrastructure as applicable.
May interact with regulators during regulatory inspections and provide relevant documentation as required.
Conduct/Manage/Support/ routine computer compliance audits (internal & external) as well as computer compliance initiatives.
Identify computer related business, regulatory or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
Establish improvement processes, as needed, or set specific measurable targets and goals linked to CSQA/GQA/GSK business needs.
Contribute to or lead the training, education, guidance and influencing of GSK R&D staff on best quality and computer compliance policy and practices.
Identify and mitigate computer compliance risks to GSK through effective audits and/or via providing advice and consultancy to GQA and business units regionally and globally.
Proactively identify, communicate, and monitor business and/or regulatory changes that could impact on quality or compliance within and across departments.
Any other duties relevant to, and consistent with, the level of responsibility of the job, as required by CSQA management.