As a Senior Software Quality Assurance Specialist, your primary responsibility is to ensure strict adherence to equipment and automated system validation requirements set forth by regulatory bodies, our corporate standards, and the site's specifications.
Key Responsibilities
Subject Matter Expertise: Act as an authority in validating equipment and automated systems.
Software Validation Proficiency: Demonstrate a strong working knowledge of software validation.
Document Review and Approval: Be responsible for thoroughly reviewing and approving all documentation related to equipment and automated systems throughout their lifecycle.
Regulatory Compliance: Ensure compliance with both internal and external validation regulations, with a special focus on meeting BSC corporate non-device software requirements.
Procedure Maintenance: Keep relevant procedures up-to-date, aligning them with BSC standards and industry best practices.
Protocols and Documentation: Provide guidance and support in preparing validation protocols, test protocols, software design specifications, and associated documents for all applications supporting the quality system and automated systems.
Project Participation: Collaborate on project teams to develop precise specifications, assess the feasibility of concepts, and provide estimates for system designs.
Guidance and Training: Offer guidance, training, and direction regarding non-device software lifecycles to staff across various functions.
Leadership: Take the lead in software validation, compliance, and Part 11 standards.
Vendor Audits: Participate in vendor audits of critical equipment vendors.
Audit Support: Present relevant documentation during both internal and external audits.
Education & Experience
Bachelor's degree in a STEM discipline relevant to the field (med device and bioprocessing)
Minimum of 5 years of experience, ideally within a medical device or highly regulated manufacturing environment.
Testing Proficiency: Demonstrate a track record of planning and executing tests for complex applications successfully.
Collaborative Skills: Showcase the ability to work effectively in a highly collaborative, matrixed environment, with a history of accomplishments that have measurable business impact.
Adaptability: Exhibit a strong sense of personal accountability and a willingness to drive changes in processes.
Quick Learner: Prove an aptitude for rapid learning and process improvement.
Communication: Possess strong verbal and written communication skills, enabling effective collaboration with team members and business partners.
Relationship Building: Display the ability to negotiate, influence, and collaborate to establish successful relationships.
Solid expereince with CSV (computer system validation)
For a confidential discussion and more information on the role, please contact Ryan Blackett.
ryan.blackett@collinsmcnicholas.ie
(021) 4911065