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QA Specialist, External Quality

QA Specialist, External Quality

TEAM HORIZONDublin, Ireland, IE
30+ days ago
Job description

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 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
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    Qa Specialist • Dublin, Ireland, IE