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Sinead Cullen
Life Science

01 507 9252
[email protected]
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Details

QA Representative API External Manufacturing


Reference:SCA012999 Location: Cork
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Analyst, QA Engineer, QA Executive, QA Manager, QA RA Engineer, QA Specialist, QA Supervisor, Quality Auditor

QA Representative API External Manufacturing
Our client, a global manufacturing pharma organisation, are currently recruiting for a QA Representative to join their Cork based team on a permanent basis. As QA Rep,
you will provide support for the quality activities at Contract Manufacturing organizations (CMOs). This role will involve international travel to ensure that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments. Around 20% travel is anticipated.

Responsibilities

  • Serve as a liaison between CMOs and the organisation
  • Provide quality oversight of CMOs including being the initial point of contact for all quality-related issues
  • Escalate quality issues at CMOs to QA management
  • Assist in the establishment and revisions of Quality Agreements with affiliates and customers
  • Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents
  • Provide quality oversight of Quality Plans
  • Coordinate and perform QA responsibilities of API shipments
  • Participate in regulatory inspection preparations with CMOs. Provide on-site support during inspections
  • Participate on the Technical Review Board
  • Evaluate and disposition API batches, if required
  • Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release
  • Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures
  • Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable
  • Ensure all processes are in an appropriate state of control
  • Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product
  • Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations
  • Participate in Annual Product Review activities
  • Participate in projects to improve productivity
Requirements
  • BS (Hons) in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences
  • 3+ years of previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering
  • Experience in quality support for API manufacturing
  • Thorough technical understanding of quality systems and regulatory requirements
  • Knowledge of pharmaceutical manufacturing operations
  • Experience in root cause analysis
  • Demonstrated application of statistical skills
  • Demonstrated strong written and verbal communications skills
  • Strong attention to detail
  • Proficiency with computer system applications
  • Excellent interpersonal skills and networking skills
  • Ability to organize and prioritize multiple tasks
  • Ability to influence diverse groups and manage relationships
For more information contact Sinéad Cullen on +353879500821 or [email protected]