Team Horizon is seeking a QA Specialist for External Quality for our client, who is a leading biopharmaceutical company based in Dublin. In this role, you will support ongoing quality assurance responsibilities in support of Contract Manufacturing oversight and quality systems.
Why you should apply:
* This is an excellent opportunity to join a world-class manufacturing operation.
* Opportunity for career progression.
What you will be doing:
* Serve as Quality Assurance support and SME for Drug Substance, Drug Product, and Finished Product manufacturing, maintaining knowledge of industry standards and regulatory requirements to ensure compliance.
* Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product, and Finished Product.
* Provide oversight to continuous quality system improvements and support implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management, and Change Control Programs.
* Work closely to build relationships with contract manufacturers' quality personnel.
* Collaborate with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs, and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
* Responsible for reviewing contractor documents, i.e., Batch records, deviations, and change controls.
* Approve specific standard operating procedures and controlled documents issued by contract manufacturing organizations.
* Support contract manufacturing organization audits, including pre-approval inspections, as necessary.
* Develop and issue quality metrics pertaining to the process quality activities.
* Trend and analyze quality aspects of technical transfer activities to measure key performance indicators, identify areas for continuous process improvements, and risk mitigation.
* Review and assess deviations; include performing risk assessments, participating in root cause analysis investigations, tracking, follow-up, and reporting/trending.
* Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, reporting/trending, and evaluating CAPA for effectiveness.
* Represent Quality Assurance to guide various projects and technical meetings, as needed.
* Responsible for documenting and reporting compliance issues to management.
* Any other duties as required by management.
What you need to apply:
* Must have experience/knowledge of drug substance, drug product, and finished product manufacturing processes in a cGMP environment.
* Minimum of 3-5 years' GMP-related experience in biopharmaceutical/pharmaceutical or related industry.
* Experience working with contract manufacturing organizations.
* Experience working on the floor in manufacturing and QA.
* Ability to provide project leadership and guide successful completion of Quality projects.
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