Senior Quality Assurance Specialist - CSV (Clinical Research), Remote-India
- India
- Permanent
- Full-time
- Lead and support Computer System Validation (CSV) activities across clinical systems (e.g., EDC, CTMS, LIMS). Acts as SME.
- Create, review, and manage validation documents such as Validation Plans, Test Scripts, Traceability Matrix, and Reports.
- Ensure compliance with GxP, 21 CFR Part 11, and other regulatory guidelines related to system use in clinical environments.
- Collaborate with IT, QA, and Functional Leads to ensure quality and regulatory expectations are met during system implementation or change.
- Participate in internal and external audits, and provide documentation support during regulatory inspections.
- Contribute to SOP development, risk assessments, and periodic reviews.
- Maintains a strong understanding of regulations and guidance as they pertain to compliance; mentors others; advises on MMS updates related to regulatory updates.
- Proficient in authoring QMS related documents, i.e. SOPs, Work Practices, Forms, Training Materials, etc. independently; mentors others; acts as SME.
- Develop CAPA plans and contribute to resolution of audit findings independently; mentors others; acts as SME
- Monitor vendors to ensure CSV processes are followed and quality is maintained independently, mentors others; acts as SME.
- Assists in internal process and document QA audits per procedure independently and in collaboration; mentors others; acts as SME.
- Ability to support document development (SOPs/ WPs)
- Support timely maintenance of multiple QMS trackers, creation & updates to Ops meetings applicable (PowerPoint).
- Graduate degree in scientific, medical, clinical discipline or related field, or related experience, Masters preferred.
- 7-10 years of experience in Computer System Validation (CSV).Prior experience in the clinical research or pharmaceutical domain is a must.
- Hands-on knowledge of GAMP 5, GxP, 21 CFR Part 11 and other applicable regulations.
- Excellent documentation and communication skills.
- Detail-oriented, process-driven, and proactive in identifying risks or gaps.
- Understanding of CROs and scientific and clinical data/terminology.
- Excellent ability to multitask, attention to detail, and organizational skills.
- Exposure to Regulatory Technology (RegTech) systems or electronic document management systems (EDMS) is preferred.