Orion Group Life Sciences are currently recruiting a QA Specialist (Centre of Excellence) on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 11-Month contract with potential to extend.
This position will report directly to the Quality Assurance COE Lead.
With energy, knowledge & innovation, the QA COE Specialist will:
* Support various site functional and cross functional tier structures.
* Completes review and approval for CAPAs, change requests, and investigative protocols and final reports.
* Responsible for the quality aspects of material and supplier management, such as compilation of material qualification pack, supplier audit review, supplier management system upkeep.
* Involved in the development and review of documentation and quality records in collaboration with other stakeholders such as QC, MS&T, Engineering and Warehouse throughout the product lifecycle e.g. method validation, facility upgrades, qualification protocols, calibration records.
* Review and approve GMP documentation / data for accuracy and completeness.
* Working cross functionally to ensure projects milestones are met in a timely manner.
* Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.
General
* A self-starter and results-focused, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
* Strong collaboration and cross-functional leadership skills.
* Strong verbal and written communication skills, project management skills.
Technical
&
Education
* Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline.
* 5 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations.
* 2 years of experience in performing the release function in a regulated environment
* Strong knowledge of qualification and implementation of Single Use technologies and raw materials for use in a GMP environment.
* Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
* Proven track record in delivering excellence.
* Knowledge of SAP, KNEAT and Veeva system is an advantage.