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Job Details

Job Summary

Responsible for ensuring process validation according to procedures to support production and product release; ensuring that trends are analyzed; accountable for ensuring compliance to and enforcing regulations, standards, policies, SOP and instructions related to design control, engineering change management and risk management. Ensure products are manufactured in compliance with written specifications. Regularly monitors the status of corrective actions/preventive actions to ensure quality issues are resolved and products are manufactured in compliance with all written specifications, standards and regulations.

Job Responsibilities:-

• New product variant development and new processes and changes to existing processes following change management and risk management procedures, ensuring compliance to procedure, regulations and standards requirements.
• Review change assessment form, Site Validation Master Plan, Equipment’s REQ, SPEC, IOVV, Drawing, Process Validation Protocol and Report, WI, MI, MLD, DHR etc. to support cross functional teams in the development, update, and release of risk management documentation.
• Lead measurement systems analysis for acceptability and develop, support, & approve validation protocols and reports for test methods.
• Define statistical testing methods and sampling in support of verification and validation testing.
• Accountable to assess, develop, write and implement protocols as needed for improved testing and quality of product including new product variant validation protocols.
• Ensure the ongoing readiness and participate in any potential internal/external audits and inspections.
• Participate in problem solving and other work improvement activities.
• Provide individual contributions in problem-solving efforts on selected projects to improve quality.
• Work with relevant departments and stakeholders to investigate non-conformances, defects, and process failures in general in order to identify areas in need of process improvement,  determine the cost of quality, and lead or participate in resolution.
• Manage and own the QA activities pertaining to the Non-Conforming Events (NCE) and Corrective/Preventive Actions (CAPA) related to manufacturing deviation
• Comply with the ISO14001 Environmental Management System policy, SOP and requirements Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
• Perform other tasks as required.

Job Requirement

Bachelor's Degree in Science / Engineering or equivalent 3-5 years or more years working in Medical Device/ pharmaceutical GMP manufacturing facility in a Quality Assurance or related capacity and knowledge of process validation and risk management. Post qualification experience in quality with focus on manufacturing and distribution. Preferred experience in regulated industries (Medical Devices).

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