Senior Quality Systems and Compliance Specialist

at  Life Science Recruitment

County Meath, County Meath, Ireland -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate28 Jul, 2024Not Specified30 Apr, 20244 year(s) or abovePharmaceutical Industry,Communication Skills,Regulatory Agencies,Delta V,Technical Operations,Sap,Trackwise,Qrm,Change Control,Regulatory Requirements,Site Inspections,Biologics,Deviations,Pharmaceuticals,VeevaNoNo
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Description:

Responsibilities:

  • Collaborate daily with cross-functional teams to address compliance issues and meet project milestones effectively.
  • Lead and participate in investigations of deviations, risk assessments, and changes, ensuring timely implementation of appropriate actions.
  • Review and approve Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance with GMP and site requirements.
  • Provide oversight to GMP readiness, technical transfers, regulatory approvals, and clinical operations.
  • Contribute to the development of training materials and provide subject matter expertise (SME) training on Quality Assurance SOPs as needed.
  • Assist in the creation and maintenance of QA SOPs, metrics, and reports to meet site requirements.
  • Identify and implement efficiencies and quality improvements to foster a culture of continuous improvement.
  • Foster strong relationships with management and colleagues to promote a safe and compliant environment.
  • Ensure timely escalation of compliance risks to management

REQUIREMENT SUMMARY

Min:4.0Max:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Science quality or a related field

Proficient

1

County Meath, Ireland