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 :
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 complianCEProviding 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 aWorks closely to build relationships with contract manufacturers quality personnelWorks 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 controlsApprove specific standard operating procedures and controlled documents issued by contract manufacturing organisationsSupport contract manufacturing organisation audits, including pre-approval inspections, as necessaryDevelop and issue quality metrics pertaining to the process quality activitiesTrend and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigationReviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting / trendingReview Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting / trending and evaluating CAPA for effectivenessRepresents Quality Assurance to guide various projects and technical meetings, as neededResponsible for documenting and reporting compliance issues to managementAny 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 environmentMinimum of 3-5 years' GMP related experience in biopharmaceutical / pharmaceutical or related industryExperience working with contract manufacturing organisations.Experience working on floor in manufacturing and QAAbility to provide project leadership and guide successful completion of Quality projects