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 in Dublin. 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:
o Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation
o 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:
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.
o 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 the clients policies.
* Regulatory and Safety Compliance:
o Ensure all activities align with client's safety standards, SOPs, and regulatory expectations.
o Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.
Preferred 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.
Additional Skills:
* Familiarity with Quality by Design (QbD).
* Proficiency in statistical analysis tools (e.g., Minitab, JMP) is a plus.
* Team-oriented mindset with the ability to thrive in a collaborative decision-making culture.
