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QA Specialist, External Quality
TEAM HORIZONDublin, Ireland, IE30+ days ago
Job descriptionServe 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 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
Description
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 :
Any other duties as required by management.
What you need to apply :
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Qa Specialist • Dublin, Ireland, IE