QA Specialist, External Quality

Team Horizon is seeking a QA Specialist for External Quality for our client, who are 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


• Hybrid & Flexible working model


• 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 supports implementing improvements at CMO's in compliance, Preventive Maintenance, Deviation Management and Change Control Programs a


• Works closely to build relationships with contract manufacturers quality personnel


• Works closely 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 & change controls


• Approve specific standard operating procedures and controlled documents issued by contract manufacturing organisations


• Support contract manufacturing organisation audits, including pre-approval inspections, as necessary


• Develop and issue quality metrics pertaining to the process quality activities


• Trend and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation


• Reviews and assesses deviations; includes 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, and reporting/trending and evaluating CAPA for effectiveness


• Represents 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 organisations.


• Experience working on floor in manufacturing and QA


• Ability to provide project leadership and guide successful completion of Quality projects