LSC have a great contract opportunity for a Quality Assurance Specialist to join a leading biotech company based in Meath.
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
Key Accountabilities
* Lead, facilitate and 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.
* 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.
* Complete QA operational duties related to product disposition including in-coming material release and the performance of detailed review of eBR prior to QP release.
* Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
* Assist in the development of training curricula and records for the QA Operations Group, providing SME training on Quality Assurance SOPs as required.
* Assist in the creation and maintenance of QA policies, SOP's and reports in line with site requirements.
Educational and Experience Requirements
* Degree qualification (Science/Quality/Technical).
* 8-10 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
* Project Manager capability with significant understanding of Operations.
* Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
* Strong written and verbal communication skills.
* Ability to think logically and be proactive under pressure.
* Ability to work as part of a team and on own initiative in a constructive manner.
* Strong attention to detail and precision in preparing and reviewing GMP documentation.
* Experience in quality management systems such as Veeva, SAP, PAS-X etc.
* Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
* Experience in direct interactions with regulatory agencies during site inspection
Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a Stamp 1G visa with a minimum of 14 months remaining or a Stamp 4 visa to apply!
We regret that we are unable to provide visa sponsorship currently. Thank you for your understanding.
Apply via this advert or contact Siobhan Cummins at 021 4777 329 if you have any more questions about this opportunity!
