Job Information
Mallinckrodt Pharmaceuticals Quality Validation Specialist in Seattle, Washington
Job Title Quality Validation Specialist Requisition JR000013967 Quality Validation Specialist (Open) Location Field Based Location - USA082 Additional Locations Job Description The Quality Validation Specialist supports the Corporate Computer Systems Validation (CSV) team and supports Corporate CSV projects throughout the company. The Quality Validation Specialist will be responsible for developing and executing and/or reviewing a variety of validation and compliance related documents/records for computerized systems to assure compliance with regulatory requirements and industry best practices. The Quality Validation Specialist will work with various stakeholders to ensure GxP computerized systems are maintained in a compliant state throughout their lifecycle. Essential Functions: General: Interprets and understands relevant laws, regulations, and standards and provides guidance, instruction, and enforcement of cGMP compliance. Reviews, and approves SOPs, validation documents, and relevant quality records (deviation, CAPA, change control, etc.) for accuracy, consistency, and compliance with relevant federal and state regulations. Develops/Authors technical documents including Quality System records (Deviations, CAPA, Change Control, Etc.), SOPs, work instructions, validation documents (VP, RA, FRS, URS, CS, DDS, IOQ, PQ, UAT, Reports, etc.), etc. in compliance to applicable laws, standards, and internal procedures. Validation: Maintains procedures associated with validation and periodic review processes. Performs and manages periodic reviews of computer systems Maintains metrics for periodic review activities. Authors and/or reviews and approves relevant validation documents (URS, FRS, CS, DS, IOQ, PQ/UAT, VP, VSR, RA, RTM, etc.). Executes validation protocols/test documents as needed. Reviews and approves executed validation protocols and associated data. Reviews Change Controls, both GxP and non-GxP. Participates in Change Control review meetings as needed. Reviews and approves protocol deviations as needed. Performs validation training to relevant stakeholders as needed. Executes and manages risk assessment, planning, and execution/mitigation activities to ensure computerized system used to support quality related operations are maintained in a qualified state throughout their lifecycles. Reviews the work of third parties contracted to perform GxP functions (validation, periodic review, etc.), as required. Manages the Global Computerized System inventory. Performs technical reviews and interprets data for accuracy for completed validations/revalidations. Participates in cross-functional design, development, improvement, and investigative activities (root cause analysis). Applies use of Quality Tools, such as FMEA, in design, development, improvement and investigative activities. Audit: Facilitates and actively participates in third party and regulatory inspection activities, as required. Other: Supports continuous improvement and cross training initiatives, as required. Comply with applicable ISO and FDA regulations as stated in the Quality Manual Embody the Company's Vision, Mission, and Values Minimum Requirements: Bachelors degree in the life sciences, engineering, or related field 3+ years of Quality System / GMP / Validation experience in the Pharmaceutical, Biotech or Medical Device industries Experience with Document Management and Training Management systems. Adaptable, customer service-oriented, positive attitude; self-starter with strong organizational skills; effective interpersonal skills for teamwork and independent work. Good working knowledge of cGMP guidelines (CFR, EMEA, etc.) and other industry standards and guidance (ISO