QA Specialist - Change Control

Pe Global

Cork

PE Global is currently recruiting for a QA Specialist/Regulatory Scientist for a Client site in Cork - Job Description Provide change control support for the manufacture and testing of clinical and commercial biologics, vaccines and small molecules Drug substance and Drug products (cross modality. Regulatory activities include: Position will involve progressing and reviewing change control documentation from all areas on site. Act as a technical expert in area of responsibility for change control management and the change control process, and work with minimum supervision. When a change is proposed, in area of change control responsibility, participate in defining change control strategies and project timelines, for the most efficient way of progressing proposed change with minimum disruption to the site. Review change control documentation received for clarity, ensuring relevant supportive data has/ will be generated and, provide relevant licence checks (if required) to help determine global licence impact. Progress and co-ordinate Health Registration requests and samples on schedule as allocated. Perform licence checks pertaining to proposed change control to assess licence impact. Disposition site change control. Establish productive working relationships with colleagues within project teams at site and other regulatory / change control subsidiaries. Link in with site in terms of what change control wouldneed to be reviewed by CMC regulatory personnel to determine impact to Clinical / commercial licenses for proposed changes. Provide Change control support as required during HA inspections. Provide change control training to the site for change originators and reviewers of proposed changes. Leverage off the networkin terms of change control guidance and support for biologics and vaccines when required. Provide guidance and support to the site in terms of change control business processes and systems. Project management skills. Requirements Degree in Biological Sciences, Biochemical engineering or related discipline. Advanced degree preferred. Min 3-5 Years biological experience -Regulatory / Technical / QA experience in biological research , development and / or manufacturing. Interested candidates should submit an updated CV, marked for the attention of Audrey audrey.brennan@peglobal.net or 00353 21 4297900. This job originally appeared on RecruitIreland.com.

2497 days ago