Quality Assurance Technical Support - IS - 12 months contract
SRG are a strategic recruitment partner to a global pharmaceutical company who are looking for Quality Assurance Technical Support to join the team in Dublin.
- Accountable for Quality oversight of processes and procedures related to Information Systems, CS & Automation compliance
- Quality review and approval of Validation documentation and SOPs as they apply to IS, CS & Automation projects
- Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
- Review of executed validation documents and reports
- Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
- Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records;
- University degree. Science or Engineering related discipline preferred.
- Relevant experience (5yrs +) working in the Medical Device, pharmaceutical or biotechnology
- Understanding of Information Systems, principles of Automation and system architectures.
- Experience in cGMP regulated environments and knowledge regarding FDA cGxP and 21 CFR Part 11 regulations and an understanding software system validation is required and working knowledge of the GAMP software development lifecycle
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.#QA #QC #pharma # pharmaceutical #lab #validation #automation #CAPA #Deviation #GMP #batch
- To apply for this position, please apply online or email a copy of your CV
your application has been submitted