Senior QA Validation Specialist

Description:

PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role.

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.
• The desired candidate should have a proven track record in QA leadership, and be comfortable working as part of a cross functional team.

Key Responsibilities:

• Quality Oversight of new equipment qualification:
• Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation
• Act as the Quality point of contact and decision-maker c & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
• Validation and Documentation:
• Quality review and approval of validation documentation, including:
• Design Specifications (DS), User Requirements Specifications (URS), and Quality Risk Assessments (QRAES).
• Validation Plans, Protocols (IQ, OQ, PQ), and associated reports.
• Ensure robust and compliant validation documentation to support site activities.
• 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.
• Ensure timely and robust implementation of change controls and CAPA records.
• 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.
• Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.

Education and Experience:

• 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.
• Excellent organizational, communication, and collaboration skills.
• Ability to work independently with minimal supervision and operate effectively across functional boundaries.
• Critical thinking and problem-solving abilities.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***