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QC Professional
e-Stone Information Technology
posted 5d ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Develop, execute, and document CSV protocols and reports for new and existing computer systems and software applications.
- Conduct risk assessments and gap analyses to identify potential quality issues and implement corrective actions.
- Develop and maintain quality documentation, including SOPs, validation plans, test cases, and reports.
- Participate in the selection, implementation, and qualification of new IT systems and software.
- Provide training and guidance to users on CSV and IT quality best practices.
- Collaborate with cross-functional teams (e.g., IT, engineering, manufacturing) to ensure compliance with regulatory requirements.
- Stay abreast of industry best practices and regulatory changes related to CSV and IT quality.
- Perform internal audits and support external audits related to CSV and IT quality.
Qualifications:
- Bachelor s degree, or a related field.
- 3-4 years of experience in CSV and IT quality assurance within a regulated industry (e.g., pharmaceuticals, biotechnology, medical devices).
- Strong understanding of GxP regulations (e.g., 21 CFR Part 11, Annex 11) and industry best practices for CSV.
- Experience with software development lifecycle (SDLC) methodologies and quality management systems (QMS).
- Excellent written and verbal communication skills, with the ability to effectively communicate technical information to both technical and non-technical audiences.
- Strong analytical and problem-solving skills.
Employment Type: Full Time, Permanent
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based on 11 employees
Flexible timing
Monday to Friday
No travel
Day Shift
e-Stone Information Technology Benefits
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