Lead Compliance Documentation Specialist
Remote working opportunity
Our client, a highly successful and growing technology company, are looking for an enthusiastic Lead Compliance Documentation Specialist to join their organization.
Our client are looking for a Lead Compliance Documentation Specialist to drive the CSV/CSA standards within the R&D organization.
Reporting to the Test Manager, the individual will be focused on delivering and ensuring the business, quality, and compliance standards are met and continuously reviewed for improvement.
This position requires excellent communication and influencing skills, written and verbal, with the ability to interact across all levels of the business
The successful candidate will have a strong interest in compliance and delivering process change in a software development environment. The candidate will be a strong team player, ability to problem solve, enjoy working in a dynamic and delivery focussed environment, and have a drive to implement change,
If this sounds like you, we want to hear from you!
Lead the CSV/CSA strategy for the Software Development process - help drive the transition from CSV to CSA standards
Ensure all audit requirements and deliverables are in place, current and adhered to (RFS, RTM, OQ, IQ) for software delivery
Ensure corrective action / preventative action measures are put in place to drive improvement
Actively participate in the internal and external audits regarding software development processes and protocols. Represent the organization in more complex risk and impact assessments.
Review audit requirements for continuous improvement aligning with industry standards
Provide training and mentoring on standards for all development resources
Keep up to date with industry regulation standards
Develop, write, review and approve SOP's and Control Documents to support software development activities
Review and approval on software release documentation - ensuring all standards are adhered to
Degree or higher in a science, engineering, IT, or similar discipline.
Requires good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
Ability to prioritize, manage multiple tasks, and meet deadlines
Excellent leadership skills with a collaborative approach
Understanding of ISO9001:2015 requirements and/or requirements for systems qualification in a regulated environment.
Proven knowledge and understanding of IT/Life Sciences industry regulations, including FDA and GxP requirements.
Experience of internal and external customer audits
Understanding of the Software Development Process
Work experience within regulated life sciences or IT industries a preference.
Work experience within a software development organization
For further information on this role please contact Amanda Duffy on (phone number removed) or email
Check out all our open jobs on our HERO Recruitment website
Email me jobs like this