Job Title: Senior QA Validation Specialist
Overview:
We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new syringe and inspection lines at our facility.
This role requires a strong understanding of Quality requirements associated with aseptic manufacturing, as well as an excellent understanding of C & Q / Validation requirements.
Key Responsibilities:
* Quality Oversight of new equipment qualification
* Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities
* Validation and Documentation: Review and approve validation documentation including Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES)
* Validation Plans, Protocols (IQ, OQ, PQ), and associated reports
* Risk Management and Compliance: Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction
* Provide input and quality oversight for change control development and implementation
* Documentation and SOPs: Write, review, and approve Standard Operating Procedures (SOPs) in alignment with Amgen policies
* Regulatory and Safety Compliance: Ensure all activities align with Amgen's safety standards, SOPs, and regulatory expectations
Requirements:
* University degree in a Science or Engineering-related discipline
* Minimum of 10 years of relevant experience in the pharmaceutical or biotechnology industry
* Proven expertise in new equipment introduction, technical transfer, PPQ execution, and lifecycle management
* Strong understanding of validation principles and regulatory requirements for C & Q / Validation (FDA, EMA guidelines)
* Experience with change control, non-conformance resolution, and CAPA implementation
About Our Client:
A leading biotech company based in Dublin South.