Company
A leading organization in the healthcare and manufacturing industry, dedicated to delivering high-quality products through innovative processes and rigorous quality standards. The company emphasizes continuous improvement, regulatory compliance, and operational excellence.
Job Description
We are seeking a skilled Senior Quality Engineer specializing in Computer System Validation (CSV) to join our team. This role is vital in supporting MES projects, ensuring compliance, and maintaining the integrity of validation activities across the organization.
Responsibilities
-Support the development and tracking of KPIs to drive continuous improvement initiatives.
-Develop strategies to implement changes to processes and procedures.
-Review and approve all CSV validation deliverables, including initial qualification, change control validation, and periodic revalidations.
-Build a working knowledge of products and contracts to ensure quality standards are met.
-Collaborate effectively with cross-functional teams, contributing to organizational processes.
-Prioritize tasks to meet departmental goals, working independently where appropriate.
-Ensure compliance with regulatory requirements and maintain GMP standards.
-Develop solutions for complex problems, evaluate deviations, and assess their impacts.
-Oversee inspections, statistical process control analyses, and audits to enforce quality requirements.
-Support compliance audits and contribute to quality oversight activities, including CQV and Risk Management.
Requirements
-Proven experience in computer system validation within regulated environments.
-Strong understanding of GMP and regulatory standards.
-Ability to review and approve validation deliverables.
-Good communication and collaboration skills.
-Ability to work independently on routine tasks and manage multiple priorities.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
58654
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Neetu Parkala
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