Manager- Quality Job in Valgenesis

Required Skills:

• 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 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 behaviour 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.
• Excellent written and verbal communication with the ability to view/ perceive from the customers viewpoint.
• 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.
• ISO Lead auditor certificates for 9001 and 27001.