Senior Quality Analyst
- Sunquest Information
- 10 - 15 years
- Bengaluru
- 5 months ago
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Job Description
Purpose:- Own, administer and update, as appropriate, the nonconformance and CAPA processes
- Author nonconformance and CAPA reports in a timely manner
- Train organization on nonconformance and CAPA procedures and expectations
- Write and update SOPs, procedures, work instructions, quality and control plans, risk plans, and notifications
- Collaboration with Subject Matter Experts (SMEs) and associated departments in support of process improvement/enhancement activities
- Monitor nonconformance and CAPA procedures, and any other quality systems as necessary, through trending analysis, compiling metrics and developing reports on a regular basis in support of Management Reviews, CAPA, and improvement initiatives
- Participate in and provide guidance to change management and product development
- Provide training to End Users on the enterprise quality management solution and various workflows (e.g. CAPA process, record content, and software use)
- Communicate with regulatory authorities and customers when required
- All other duties and responsibilities as assigned
- Analytical skills that include trending and evaluation of data with the ability to identify potential process problems.
- Team (matrix) leadership across global, various company departments.
- Mastery of investigational tools for successful root cause analysis.
- Organizational, planning, project management and process improvement skills.
- Knowledge of industry regulations and standards.
- Independent and self-driven to excellence.
- Experience with auditing, quality tools and process improvement techniques.
- Excellent oral and written communication skills.
- Excellent problem-solving skills
- Strong detail orientation
- Bachelor s degree or equivalent
- 10 years quality assurance experience in a regulated industry
- Experience with Healthcare Software
- Quality or Regulatory Certifications (RAC, ASQC)
- 3 years of CAPA and root cause investigation experience is preferred
Job Classification
Industry: Software ProductFunctional Area / Department: Quality AssuranceRole Category: Business Process QualityRole: Quality AnalystEmployement Type: Full timeContact Details:
Company: Sunquest InformationLocation(s): Bengaluru
Keyskills: Root cause analysis Change management Manager Quality Assurance Project management Process improvement Quality systems Senior Quality Analyst Healthcare Continuous improvement Quality management
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Sunquest Information
Sunquest Information Systems Inc. provides diagnostic informatics solutions to laboratories worldwide. Since 1979, Sunquest has helped laboratories and healthcare organizations enhance efficiency, improve patient care, and optimize financial results. Our capabilities include multi-site, multi-discip...
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