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Convatec

Solution Owner - Quality Management System (Regulatory & Quality)

RemoteIndia only· UTC+0…UTC+3
Published
Role
Product
Experience
Senior
Employment
Full-time
Company size
Enterprise
Salary not disclosed
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Open to IN only · UTC+0…UTC+3. Set where you work from to check your eligibility.

No BS summary

Senior Solution Owner for Trackwise-driven Quality Management Systems. Needs 5+ years in IT systems operations focused on regulatory & quality systems, mandatory Trackwise experience and familiarity with GxP/21 CFR Part 11. Must support UK/EU time zones (India-based remote acceptable).

Core skills

Trackwisesystem configurationsystem validation

Required skills

GxP21 CFR Part 11SQLRESTSOAPGitHubSLA managementchange management

Optional skills

cloud servicesITIL 4Prince 2GMPrelated certifications

What you'll do

  • Design, configure, test, deploy, maintain, and improve applications.
  • Collaborate closely with QA, IT, and business stakeholders to define system requirements and solutions.
  • Orchestrate clear, efficient, and well-documented configurations and scripts, following best practices and compliance standards.
  • Participate in system reviews and validation activities to ensure system quality, regulatory compliance (e.g., GxP, 21 CFR Part 11), and data integrity.
  • Troubleshoot, debug, and upgrade existing systems to ensure optimal operations and minimal downtime.
  • Contribute to the full system lifecycle, from requirements gathering and design through deployment, training, and ongoing support.
  • Stay updated with emerging technologies and apply relevant advancements to improve system functionality.
  • Work closely with QA and compliance teams to ensure that applications meet the highest quality and regulatory standards.
  • Assist in project planning, task estimation, and risk identification, proactively addressing potential issues and proposing effective solutions.
  • Provide ongoing support, training, and mentorship to users and administrators.

What they require

  • Min. 5 years of experience with IT Systems operations, with a focus on Regulatory and Quality Solutions.
  • Trackwise experience is required.
  • Prior experience managing Trackwise version upgrades/customization will be an added advantage.
  • Proven experience with Regulatory & Quality Systems.
  • Proficient in system configuration, SLA Management and business stakeholder management.
  • Strong understanding of data management and regulatory requirements (e.g., GxP, 21 CFR Part 11).
  • Experience with software development methodologies (e.g., Agile, Scrum) and system validation practices.
  • Familiarity with database technologies (e.g., SQL) and web services (e.g., REST, SOAP).
  • Experience with version control systems (e.g., GitHub) and change management processes.
  • Excellent problem-solving and analytical skills, with attention to detail and data integrity.
  • Strong communication and teamwork abilities, with experience collaborating across functional teams.
  • Experience with cloud services and technologies is a plus.
  • Ability to lead training sessions and support end-users in a regulated environment.
  • A Masters / Bachelor's in IT, or related fields.
  • Related certifications (ITIL 4, Prince 2 or GMP) is a plus.

Benefits

  • Equal employment opportunities statement.
  • Recruitment formal process via official Convatec email; contact careers@Convatec.com (safety/scam notice).

UK medical products and technologies company

HealthcareEnterpriseconvatec.com
Salary not disclosed