Sr. Qualification Engineer - Katalyst Healthcares & Life Sciences
Newark, CA 94560
About the Job
Responsibilities:
- Provide independent technical leadership and accountability for overall IT Infrastructure Qualification and CSV efforts.
- Ensure quality and compliance is met in accordance with established procedures and standards of the Quality Systems by applying critical thinking on qualification and validation work.
- Plan, generate, review and/or approve qualification or validation packages for IT Infrastructure or GxP systems in support of compliance activities.
- Develop or assist with change controls, CAPAs, deviations, exceptions required as part of qualification/validation efforts.
- Engage with IT stakeholders in supporting continuous improvements to the existing procedures and policies in relation to compliance and update those as necessary.
- Perform gap analysis & necessary remediation efforts on current IT Infrastructure to ensure compliance with Part 11 and Annex 11.
- Collaborate/lead/participate in decision making and make recommendations regarding best options for qualification of computerized systems.
- Maintain close communication with stakeholders and team members to keep apprised of IT Infrastructure needs, & impact on GxP processes or operations.
- Collaborate with Revance approved vendor personnel in coordinating qualification or validation efforts to ensure successful system implementations.
- Perform system assessments based on version upgrades/release updates on SaaS/Cloud based GxP systems and ensure all the required verification and validation efforts are performed per the assessments conducted.
- Facilitate the computer system validation risk assessments i.e. System level, Requirement level risk assessments, & System and Data Audit Trail assessments etc.
- Assist IT staff with business process deliverables such as process flows, data flows, user/operating procedures, work instructions and forms for GxP computerized systems.
- Perform System Periodic Reviews ensuring that the systems are maintained in their validated state.
- Support Regulatory inspections and internal and partner audits, and implements corrective actions as needed in CSV.
- Minimum of seven (5-7) years or more in the pharmaceutical industry with GMP experience.
- Understanding of Validation Life Cycle approach and practical working knowledge of computer system validation/computer software assurance requirements.
- Knowledge of infrastructure qualification or validation of computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
- Demonstrate ability to effectively manage multiple projects/priorities and good understanding of SDLC phases and phase gates.
- Experience with EDMS, VLMS, LMS and working knowledge of IT Infrastructure systems (AD, Backups, VMware, Monitoring at minimum).
- Demonstrate excellent written and oral communication skills.
- Effective time management and interpersonal skills.
- Must work effectively within teams with rapidly changing priorities.
- Demonstrates analytical problem-solving skills.
Source : Katalyst Healthcares & Life Sciences