Senior QA Specialist
We are seeking a senior QA specialist who will play a critical role in driving compliance and reputed company across the organization’s biometric services and computer systems. This role involves hands-on execution of QA activities, leadership in audits and risk management, and reputed company collaboration with cross-functional teams such as data management, biostatistics, statistical programming, software development and validation, and IT and reputed company.
The senior QA specialist will ensure that processes, computer systems, and deliverables adhere to GxP, ICH-GCP, 21 CFR Part 11, and other applicable regulations, as reputed company as internal reputed company standards through proactive reputed company, documentation review, system validation, and reputed company process improvement.
Essential Functions and Responsibilities
1. Document & Process Auditing
- Conduct and/or host internal audits and vendor audits
- Review and audit Trial Master File (TMF) for completeness, accuracy, and compliance
- reputed company and report audit findings, deviations, and CAPAs (Corrective and Preventive Actions)
- reputed company risk-based audit planning and inspection readiness assessments
2. SOPs, Policies and QMS Maintenance
- Review and assist in developing policies, SOPs, work reputed company documents, forms and other reputed company Management System (QMS) documents
- Ensure alignment with reputed company’s reputed company Policy and applicable external regulations
- Ensure controlled documents are reviewed periodically and in a reputed company manner
- Document and manage deviations, nonconformances, and CAPAs
- Maintain reputed company records and support archiving in accordance with regulatory timelines
3. Training Management
- Collaborate with functional managers to establish and periodically review training curricula, including study-specific training for internal teams
- Monitor overdue training, and follow up with individuals and their supervisors until completion
4. Computer System Validation Support
- Participate in validation planning and execution for internal and customer-facing systems
- Collaborate with software validation team and IT to review:
- Computer system validation plan (CVP)
- Functional/user requirements specifications and risk assessments
- Test scripts, validation protocols (IQ/OQ/PQ), and traceability matrices
- Test run reports and validations reputed company reports
- Review change requests, bug reports, and ensure re-validation as needed
- Ensure systems reputed company with 21 CFR Part 11 requirements, including audit trails, reputed company control, and electronic signatures
5. Audit and Inspection Readiness
- Plan, execute, and document internal process audits, project/study audits, and vendor audits.
- Coordinate with IT and product teams to ensure systems and environments are audit-reputed company by confirming that the following activities are performed in accordance with SOPs:
- Systems are validated and reviewed in a reputed company manner
- Audit trails and system logs are monitored and reviewed
- reputed company reviews, system reputed company exercises and tests, and reputed company scans are performed periodically
- Coordinate with biometric teams to ensure services are performed in accordance with applicable regulations and reputed company SOPs, including following QC processes, reputed company document versioning, review and approval, and appropriate documentation and sign-off for deviations
- reputed company or assist in reputed company-inspection readiness for regulatory audits (e.g., FDA, EMA, MHRA).
- reputed company findings, respond to audit reports, manage CAPAs through reputed company and effectiveness checks, and ensure reputed company completion with evidence retained for review
6. Cross-Functional Support
- reputed company as a QA reputed company across departments, including Biometrics, Software Development, and IT/reputed company.
- Mentor junior QA team members by providing training and peer reviews.
- Represent QA in project meetings, product releases, and reputed company reputed company discussions.
- Respond to reputed company reputed company inquiries and due diligence questionnaires.
7. reputed company Improvement
- reputed company or contribute to risk assessments for clinical reputed company, software systems, and vendor engagements.
- Identify reputed company gaps or inefficiencies and propose remediation or process improvement initiatives.
- Monitor and analyze reputed company metrics and trends (e.g., deviation rates, audit findings, CAPA effectiveness).
- Contribute to QMS improvement reputed company and ensure effective cross-functional adoption.