Computer System Validation

Location: Washington, DC

Job Description

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!



Ideal Qualities

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others.
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing growth.
  • Ensures activities are efficient, optimized, and client centric.
  • Highly motivated and organized, solutions-oriented leader
  • Curious and adaptable - has the ability to transform knowledge into actionable activities
  • Able to produce results in a fast paced, collaborative environment


Essential Duties and Responsibilities

  • Scope would include all aspects of the Computer Systems Validation (CSV) program.
  • Direct site execution of and adherence to global CSV policies and procedures.
  • Execute on implementation tasks, work prioritization and support escalation management activities while ensuring the highest level of compliance with regulatory agencies.
  • Track changes to the regulatory environment and implement processes and procedures enabling the client to meet ongoing requirements such as 21 CFR Part 11, EU Annex 11, and data integrity.
  • Closely work with the Senior Manager for Computer Systems Validation and relevant IT/business counterparts to support the implementation and validation of ongoing software development projects.
  • Develop and manage project documentation for SDLC & COTS requirements during computer system implementation projects including developing user and functional requirements, technical and functional business process flows, use case, test case and test script documents, and perform functionality, usability and testing during required project phases.
  • Provide oversight and review all aspects of testing associated with multiple concurrent software development and/or infrastructure related projects.
  • Utilize knowledge of all phases of Software Project Development Life Cycle and contribute to Analysis, Design, Development, Testing and Deployment of Software Applications.
  • Ensure project deadlines and performance standards are met while communicating status accordingly; respond to inquiries from relevant business and IT stakeholders and provide status updates on a frequent basis.
  • Contribute and collaborate on CSV activities for enterprise level (multi-site projects), lab, and manufacturing systems.
  • Work collaboratively to ensure the development of CSV best practices.
  • Able to produce results in a fast paced, collaborative environment


Qualifications

  • Minimum requirement is a Bachelor’s Degree in Computer Science, Sciences or a related education.
  • Minimum 5 years Professional experience in managing quality / compliance in the regulated environments in a Pharmaceutical/Life Sciences Organization.
  • Proficiency in Computer System Validation in a GXP environment.
  • Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles.
  • Strong knowledge of GMP, GAMP5, SOPs and quality systems.
  • Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, ICH 10).
  • Strong knowledge of IT compliance SOPs including change control practices/strategies, and system risk assessments.
  • Proficient in MS Word, Excel, Power Point and other applications.
  • Strong written and verbal communication skills.
  • Ability to communicate and work independently with scientific/technical personnel.
  • Ideal candidate will have experience in validating software applications like SAP, Master Control (MC), and Compliance Wire (CW).
  • Prior experience in managing Data Migration and Archiving related projects.