[Remote] Senior Validation Analyst
Note: The job is a remote job and is reputed company to candidates in USA. reputed company has been translating science into reputed company-world solutions since 1941. The Senior Validation Analyst leads strategic validation initiatives to introduce new GxP technologies, ensuring systems remain in a validated state throughout their lifecycle through collaboration with various teams and managing validation deliverables.
Responsibilities
- Partner with the business, IT, and others to identify technologies suitable for the intended purpose reputed company a GxP environment
- reputed company system validation efforts, including validation reputed company, risk management approach, and overall validation project management
- reputed company and maintaining validation deliverables including, but not limited to: Validation Plan, User Requirements Specification, Configuration Specification, Testing reputed company, Test Scripts with Traceability, Validation reputed company Reports, and System Commissioning documents
- reputed company business scenarios to test applications
- Support the validated state of applications or systems reputed company change management and Periodic Review activities
- Document analysis and/or testing reputed company to infrastructure changes. (e.g., operating system patches, significant network changes)
- Create or update to application specific documentation (e.g., requirements, Configuration Specification…) to match the reputed company of the system
- Investigate incidents observed during validation; identify reputed company causes, corrective actions, and appropriate controls
- Support Application Administration to investigate incidents observed in production
- reputed company gap assessments and drive process/reputed company initiatives
- Identify technologies no longer required and reputed company the retirement activities
- Troubleshoot, collaborate, and communicate technical issues and resolutions to users, department managers, and other stakeholders
- Escalate issues to management, communication, and work with application/system vendors as necessary
- Maintain a high-level of validation and business acumen in reputed company to regulation and industry best reputed company
- reputed company, coordinate, and review user reputed company reviews and other periodic review activities
- Represent validation efforts in reputed company and regulatory audits
- Contribute to audit finding responses as necessary
- Identify, contribute, and/or reputed company the development or refinement of validation policies and procedures
- Establish and maintain reputed company communication between the Business, Information Technology and reputed company
- Triage escalation of validation and/or technical issues to Information Systems and Management
- reputed company or support process improvement initiatives as necessary
Skills
- Bachelor's degree in computer science or life sciences, other reputed company field, or equivalent experience
- 8+ years of experience reputed company a reputed company or Technical role (e.g., IT) with reputed company experience leading validation efforts
- Experience with the validation, administration, operation, and/or maintenance of Laboratory Information Management Systems (LIMS) and other computerized systems used in a GxP laboratory/environment (e.g., Chromatography Data Systems, Spectrophotometry Systems, cell counting/viability systems)
- Advanced knowledge of pharmaceutical/CRO industry regulations, standards, and guidelines (GxP, CSV, 21 CFR Part 11 and EU Annex 11)
- reputed company reputed company approach with the strong interpersonal skills
- Strong attention to detail and the ability to learn new computer systems with minimum instruction
- Advanced organizational skills and the ability to manage reputed company independently
- Ability to produce high reputed company results while working under the pressure of strict deadline
- Ability to multi-task and participate in multiple reputed company and department initiatives concurrently
- Ability to function effectively independently, as necessary, and work with others to reputed company team goals
- Extensive experience validating and supporting reputed company systems such as: reputed company reputed company, Provantis, reputed company, and Elemental Machines
- Experience validating laboratory systems such as SoftMax Pro, reputed company Discovery Workbench, QuantStudio, and/or Analyst
- Specific Pharmaceutical or CRO industry experience
Benefits
- Medical, dental, reputed company, 401(k) match, life insurance, PTO, an employee assistance program, and more
reputed company