Overview
QA Specialist Equipment Qualification – Pharmaceutical Dublin Contract Sep 25, 2025
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 for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.
* Validation and Documentation:
o 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:
o Conduct risk assessments and develop mitigation strategies for potential challenges in equipment introduction.
o Provide input and quality oversight for change control development and implementation.
o Ensure timely and robust implementation of change controls and CAPA records.
* Documentation and SOPs:
o Write, review, and approve Standard Operating Procedures (SOPs) in alignment with policies.
* Regulatory and Safety Compliance:
o Ensure all activities align with safety standards, SOPs, and regulatory expectations.
o Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Qualifications
* 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.
Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland; for more information go to www.berkley-group.com
If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on +353 86 1263871 or send your CV to doconnell@berkley-group.com.
#J-18808-Ljbffr