Syntricate Technologies

Veeva Validation Lead Developer

Syntricate Technologies$100K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5-7 years of experience in Computer System Validation (CSV) within regulated environments
  • Familiarity with software development life cycle (SDLC) and software testing life cycle (STLC)
  • Proven ability to create and maintain comprehensive validation documentation, including Compliance Plans and Risk Assessments
  • Experience developing Standard Operating Procedures (SOP) and Work Instructions (WI)
  • Strong proficiency with JIRA, Client-ALM, and qTest tools
  • Understanding of validation and testing in agile project contexts
  • Required GxP experience, with specific knowledge in 21 CFR Part 11 compliance.

Responsibilities

  • Conduct validation and verification activities for computerized systems
  • Draft and manage validation documentation, ensuring compliance with regulatory standards
  • Develop and revise standard operating procedures and work instructions
  • Collaborate with project teams to incorporate Agile methodologies and principles into validation processes
  • Perform risk assessments related to validation and compliance issues
  • Facilitate testing phases, including user acceptance testing (UAT) and regression testing
  • Ensure timely delivery of validation deliverables in alignment with project timelines.

Benefits

  • Comprehensive health benefits including medical, dental, and vision coverage
  • Generous paid time off policy and holiday schedule
  • Employee development programs and training opportunities
  • Flexible work hours or remote work options
  • Support for continuing education and professional certifications.
Full Job Description
Required Skills:
  • Demonstratable Experience in Computer System Validation (CSV)
  • Experience in software development processes (SDLC) and software testing life cycle (STLC)
  • Experience in drafting, reviewing, revising, and maintaining validation documents (CSV), including Compliance Analysis, Compliance Plan, Change Control Document, User & Functional Requirement documents, Risk Assessments (Risk Register), Test (ST/UAT/Regression) Protocol, Test Defect Report, Test Summary Report, Compliance Summary Report, Traceability Matrix, Hypercare Plan, Operation Run Book and other validation & technical documentation.
  • Experience in drafting Standard Operating Procedures (SOP) and Work Instructions (WI)
  • Strong knowledge of JIRA, Client-ALM, qTest tools
  • Knowledge of validation & testing in projects implemented using agile methodology
  • Knowledge about Agile techniques like: User Stories, Continuous Testing, tasks, etc.
  • Ability to take and understand the commitment to deliver the product on time.
  • GxP experience is required
  • Experience of validation support for 21 CFR Part 11 implementation in Pharma industries.
  • Experience working within a FDA/Other regulated pharma industry.

About Syntricate Technologies

Syntricate Technologies Careers

Joining Syntricate Technologies presents an unparalleled opportunity to advance a career in technology with a company at the forefront of digital innovation. Syntricate Technologies is renowned for its commitment to leadership, diversity, and leveraging technology to solve complex problems. This is where professionals come to not just seek job opportunities but to forge lasting careers in an environment that values growth and leadership.

Explore Career Opportunities

Syntricate Technologies is actively hiring and offers a variety of positions that cater to different skills and career aspirations. From entry-level roles to leadership positions, the potential for professional advancement is nearly limitless. Syntricate Technologies is not just a company; it's a place where talented individuals can thrive.

Innovation and Professional Growth

At Syntricate Technologies, innovation isn't just another buzzword—it's the cornerstone of the company culture. Employees are encouraged to push the boundaries of what is possible, bringing groundbreaking solutions to the table. With a team of dedicated professionals, Syntricate Technologies fosters a culture of continuous improvement and professional growth.

Diversity and Inclusion

Syntricate Technologies believes that diversity fuels innovation. With a commitment to creating a diverse and inclusive workplace, the company actively seeks to hire individuals from various backgrounds and experiences. Diversity training is integral, ensuring that all team members feel valued and understood.

Internship Programs and Employment Benefits

For those starting their careers, Syntricate Technologies offers robust internship programs that provide real-world experience and networking opportunities. Interns at Syntricate Technologies gain invaluable industry insights and professional skills that are crucial for future employment. Full-time employees enjoy a comprehensive benefits package that supports both their professional and personal lives. Benefits at Syntricate Technologies are designed to ensure employees are healthy, happy, and secure.

Applying for a Position

To apply for a position at Syntricate Technologies, candidates should prepare a resume that highlights relevant experience and skills. The interview process is designed to assess not only professional qualifications but also a candidate's fit within the company culture. Syntricate Technologies values curiosity, creativity, and a passion for technology.

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51 employees
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