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20 Tracelink Jobs

Regulatory & Quality Compliance Specialist, Senior

4-6 years

Pune

1 vacancy

Regulatory & Quality Compliance Specialist, Senior

Tracelink

posted 1hr ago

Job Description

Assist the Regulatory and Quality Compliance (RQC) team to ensure compliance with TraceLink procedures and relevant global regulations and standards (ISO 9001, FDA 21 CFR Part 11, EU Annex 11), and to ensure ISO certifications are maintained. Implement process improvements across the organization and collaborate with other functions to holistically create a culture of total quality and compliance. Improve quality management system processes, especially related to training, document management, records management, internal auditing, and KPI reporting.
Responsibilities
  • Ensure the company s products and services organizations are compliant with relevant government and industry regulations including but not limited to: ISO 9001, US FDA 21 CFR Part 11, and EU Annex 11 for the development and maintenance of regulated software products and related services
  • Manage revision and approval of the Quality Management System (QMS) documents, including but not limited to periodic SOP reviews, change control, document management system (eQMS), control of records, electronic signatures, and good documentation practices
  • Perform internal quality audits of the organization, including authoring plans and reports, tracking findings, and follow up
  • Assist with management of the QMS employee training program, compliance monitoring, eLMS system, and continual improvement efforts
  • Assist with Corrective and Preventive Action (CAPA) investigations, root cause analysis, and authoring reports
  • Maintain metrics / Key Performance Indicators (KPIs) for operational effectiveness monitoring of key department functions
  • Assist with internal tool assurance activities including annual inventory reviews in collaboration with system business owners, periodic reviews, risk assessments, and performing tool validation/qualification where required
  • Interface with RQC management, and all levels of functional management throughout the corporation to create, implement, improve, and monitor quality practices and procedures in accordance with corporate Quality Management System (QMS)
  • Support software approval, release, and deployment activities, as needed and on a rotating basis
  • Stay abreast of industry and federal regulations and standards that inform the QMS including ISO 9001, Part 11/Annex 11, GAMP5, data integrity, and software validation/assurance
  • Provide input and guidance from a regulatory and quality perspective to functional areas of the corporation to facilitate decision making
Skills and Qualifications
Essential
  • BA/BS in engineering, computer science, information systems, or other scientific discipline
  • General knowledge of the life sciences / healthcare / pharmaceutical industries, drug supply chain management, computer system validation, and/or medical devices
  • Demonstrated knowledge of ISO 9001 or similar standards
  • 4-6 years performing or managing quality, audit, and/or software validation/qualification activities within the pharmaceutical, medical device, clinical trial, or other related industry
  • Familiarity with cloud-based software, agile software development, and automation.
  • Ability to work independently and as a team member in fast-paced environment, in an effective and flexible manner
  • Highly developed and proven written and verbal communication skills
  • Strong interpersonal skills to be able to build trust and relationships with cross-functional teams, challenge constructively, and collaborate and deliver results as a team.
Desirable
  • Experience with global teams across time zones and geographies
  • Familiarity with US FDA 21 CFR 820/211, FDA Computer Software Assurance (CSA), GAMP5
  • Experience with Medical Devices, Data Integrity, Data Privacy, Artificial Intelligence (AI)

Employment Type: Full Time, Permanent

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What Tracelink employees are saying about work life

based on 47 employees
73%
93%
67%
67%
Flexible timing
Monday to Friday
No travel
Day Shift
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Tracelink Benefits

Work From Home
Free Food
Cafeteria
Soft Skill Training
Health Insurance
Team Outings +6 more
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