LSC have a great contract opportunity for a QA Validation Specialist to join a leading biotech company based in Dublin.
If you have 5+ years of experience and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Lead, facilitate and/or participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
- Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
- Participate in project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release.
- Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
- Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
- Review and Approval of validation lifecycle documents and reports.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Postgraduate qualification in an engineering or science discipline would be advantageous (Science/Quality/Technical).
- Min 5 years' experience, ideally in Quality Assurance / Validation within the Biological and/or pharmaceutical industry as part of a computer systems validation, validation, engineering or IT/OT function.
- Experienced in the execution of commissioning and qualification/validation of computerized systems and process equipment (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
- Knowledge of GAMP requirements to the qualification and validation of computerised systems a distinct advantage.
For our contracting positions in Ireland's pharmaceutical industry, applicants must possess a Stamp 1G or a Stamp 4 visa. We apologize for any inconvenience, as visa sponsorship is not available at this time. Thank you for your attention.
Apply via this advert or contact Sarina Abdulha on 021 4777 329 if you have any more questions about this opportunity!
