Quality Validation Engineer

We are hiring a highly dedicated Quality Validation Engineer who will manage specification, process validation, test method validation, stability study, and transportation study in our Medical Device / Pharmaceutical sector.

Key Responsibilities :

• Manage validation procedures (including equipment, process & test method) and validation master list.
• Establish validation documents and carry out validation activities, including performance qualification and test method validation.
• Conduct periodic validation reviews (PVR) in a timely manner and perform revalidation when required.
• Generate stability study documents and execute stability studies as requested by customers.
• Administer test equipment (such as tensile testers, smart scopes, etc.) and ensure proper operation according to requirements.
• Manage customer change requests (including documentation, QAD updates, etc.).
• Revise raw material / product specifications when necessary.
• Identify and initiate improvement activities through data analysis from manufacturing records, such as capability studies and risk analyses.
• Lead / support non-conformance investigations, including risk assessment, root cause analysis, and implementing corrective & preventive actions.
• Establish and execute stability and transportation study documents as per customer requirements.
• Support internal, supplier, and external audit processes.
• Stay updated with new technology and maintain in-depth knowledge of products / raw materials to support new product introductions or improvements.
• Comply with all SOPs, work instructions, and guidelines that have been trained on.
• Perform other duties as assigned by superiors and complete tasks within the specified time frame.

Key Requirements :

Join us in our mission to make a positive impact on healthcare through innovation and excellence in manufacturing. If you are a motivated professional with a passion for this field and a desire to thrive in a dynamic environment, we want to hear from you!

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