Syntricate Technologies

SOX, GXP Developer

Syntricate Technologies$90K — $130K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • 8+ years of Pharma Audit experience focused on SOX, GXP applications, and technical platforms.
  • Strong understanding of US FDA regulations and updates in the pharmaceutical sector.
  • Proven hands-on experience leading discussions with corporate auditors and external audit teams.
  • Ability to support evidence phases for governmental inspections effectively.
  • Experience in developing and updating governance documents related to data management.

Responsibilities

  • Lead assessment discussions with corporate auditors and external audit teams.
  • Drive continuous improvement initiatives to achieve zero Level 1 and Level 2 audit findings.
  • Support the identification and refinement of ambiguous or obsolete data requests.
  • Develop a comprehensive BAP Audit Playbook to streamline processes.
  • Train and mentor audit team members for a phased transition of audit responsibilities.
  • Draft and maintain standard operating procedures (SOPs) and work instructions (WIs) for data management.
  • Co-chair annual business continuity and disaster recovery tabletop exercises.
Full Job Description
Job Description:
  • Dedicated 8 + years of Pharma Audit Experience for SOX, GXP Applications and Technical Platforms
  • Good Understanding of US FDA and other Pharma Regulations updates.
  • Hands on exp of Leading assessment discussions with Corporate Auditors and External Audit Team
  • Support data evidence phase for external governmental inspections
  • Lead assessment discussions with Corporate Auditors and External Audit Team
  • Drive improvements to achieve Zero Level 1/Level 2 Audit findings
  • ssist in identifying, eliminating or refining data requests which are obsolete and/or ambiguous
  • Develop a BAP Audit Playbook
  • Train and mentor audit team with the goal of transitioning audit responsibilities over a period
  • Draft and update governance documents (SOPs, WIs, etc.) pertaining to backup, storage, platform, and Data Centers/Server Rooms.
  • Build a self-service checklist for audit and inspection readiness
  • Design and drive closure of remediation activities coming out of Audits
  • Co-chair annual Business Continuity / Disaster Recovery Tabletop exercises

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.

Stay Connected with Syntricate Technologies Careers

Interested candidates are encouraged to explore the various job opportunities on the Syntricate Technologies careers page. Stay updated with the latest company news, employment trends, and career tips by subscribing to the Syntricate Technologies careers newsletter.

Join Syntricate Technologies

Discover the career possibilities that await at Syntricate Technologies. Search open positions that match your skills and interests. Syntricate Technologies is looking for passionate, driven, and innovative team players ready to contribute to a leading technology company.

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Learn more about Syntricate Technologies
Size
51 employees
Industry

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