Overview
PE Global is currently recruiting a Quality Assurance Specialist for a 11 month contract, with a leading multi-national client based in Swords
This is a hybrid role, working 1 day per week from home.
An exciting opportunity has arisen for a Quality Assurance COE (Center of Excellence) Specialist to join our client’s team in their Biotech facility in Swords, Co. Dublin. The role ensures that the QA team objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers, as well as meeting Health Agency regulations and all other applicable governing regulations.
This position will report directly to the Quality Assurance COE Lead for Biotech Dublin.
Responsibilities
* Support various site functional and cross functional tier structures.
* Complete 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.
* Work 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.
Education/Experience
* 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.
* Knowledge of SAP, KNEAT and Veeva system is an advantage.
How to apply
Interested candidates should submit an updated CV.
Please click the link below to apply, call Chloe on 086 0200448 or alternatively send an up to date CV to chloe.slingsby@peglobal.net
Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland
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