Job Description
ValGenesis is looking for Quality Analyst in the Chennai location with the below-required skills.
Required Skills:
- Excellent written and verbal communication with the ability to view/ perceive from the customers view point.
- Should have eye for details and diligent in work performed with follow-up to ensure that work is performed right first time.
- Should have high interpersonal skills to motivate and move along within the QA team and also with the other teams in the organization.
- Ability to interact with customers with clear responses to resolve the findings. (Knowledge in GAMP 5, ISO 9001, 27001, ITIL, GDPR and SSAE 16 is preferred)
- Elucidate requirements from user stories and use case scenarios bringing out behavior orientation and derive non-functional requirements and associated specifications.
- Create training plan, role based training matrix, competency assessment and maintenance of training records in line with the Life- science’s needs.
- Compliance of product and project requirements with customer feedback and effective resolutions.
- QMS development, periodic review, revision and implementation of SOPs / procedures with formal change, impact assessment with continual improvements.
- Knowledge in Agile and SDLC models and verify deliverables flawlessly from requirements to release to customers.
- Excellent knowledge in determining root causes with Corrective and preventive actions.
- Ability to perform risk identification using tools like FMEA with mitigation strategies including risk control methods/ measures. Manage risk assessment with organization assets and associated control and response plans.
- Ability to handle deviations with CAPA, incident management, Non-conformance reports and audits.
- Ability to arrive at specifications for product, service both qualitative and quantitative data.
- Be hands on in terms of creating QC plans, Project Plans, Configuration Management Plans, Validation protocols and monitor them to closure. (Knowledge in Life sciences specific terminologies is preferred).
- Ability to create performance baselines and estimates based on project/product data.
- Understanding customer expectations of and needs from a product with adherence to legal and regulatory standards.
- Early warning and reporting to top management on quality issues.
- Knowledge in statistical analysis and inferences is preferred.
- Prefer knowledge in life sciences domain with security and basic programming languages / scripts
Qualifications:
- Degree in Engineering and/or Business Administration and/or Life-sciences relevant domain is preferred.
- Quality control and other relevant certification is preferred
Role - Quality Assurance/Quality Control Executive
Industry Type - IT-Software, Software Services
Functional Area - IT Software - QA & Testing
Employment Type - Full Time, Permanent
Role Category - QA/Testing/Documentation
Education:
UG :B.Tech/B.E. in Electrical, Electronics/Telecommunication, Computers
PG :M.Tech in Computers, Electrical, Electronics/Telecommunication