Are you interested in progressing your career in life sciences? Are you ready to challenge yourself and join a global leader in pharmaceuticals? If you have a background in Quality Assurance and GxP Systems Validation, this could be the perfect opportunity for you!
Job Description
We are currently hiring an Audit Support Specialist to support our client's audit team with responses to inspections and audit requests. You will be required to coordinate evidence collection, maintain audit resources, analyse quality and audit data, and improve the processes and tools used to manage audit support. GxP and IT Validation knowledge is required.
Key Responsibilities
IT validation and audit support
- Coordinate evidence requests for GxP regulatory inspections, customer audits and internal quality audits.
- Work with IT system Subject Matter Experts (SMEs) to obtain accurate evidence within agreed deadlines.
- Understand IT validation documentation, system lifecycle (SLC) evidence and data integrity requirements.
- Support mock audits and inspection readiness activities.
Data analytics and reporting
- Build, maintain and enhance Power BI dashboards, reports and queries.
- Analyse audit requests, internal quality observations and external regulatory inspection findings.
- Identify trends, potential compliance gaps and opportunities for remediation.
- Produce weekly status reports covering audit activity, outstanding requests and improvement initiatives.
Key Requirements
- Experience with GxP Systems, IT Validation and Data Integrity
- Experience supporting IT validation activities in a regulated pharmaceutical or Life Sciences environment.
- Understands validation evidence, data integrity, compliance expectations and audit readiness.
- Practical exposure to audits, inspections, audit evidence, quality processes or compliance support. Understands how to coordinate evidence requests and recognise potential gaps.
- Ability to build dashboards, analyse datasets and maintain or improve existing reports and queries
- Experience maintaining and configuring existing workflows, forms, routing and data capture processes, ideally utilizing Smartsheets
- Has experience or demonstrable practical ability using AI or automation to streamline repetitive tasks and improve workflows.
- Schedule: Monday to Friday; 5am - 2pm or 2pm - 11pm
Benefits
- Competitive and attractive employee compensation package
- Pension contributions
- Health insurance
- Paid holidays
Location: Remote | Ireland / UK