Quality Assurance Professional

As a Validation Engineer, you will play a critical role in ensuring the quality and integrity of our products by planning, coordinating, and executing validation activities. This includes developing validation protocols, analyzing data, and preparing comprehensive reports that meet regulatory and quality requirements.

• Develop and execute validation protocols (IQ, OQ, PQ) in accordance with regulatory guidelines.
• Conduct risk assessments and define validation strategy for new and existing manufacturing processes.
• Analyze process performance data and identify opportunities for improvement and optimization.
• Prepare and maintain validation documentation, including protocols, reports, deviations, and change controls.
• Collaborate with cross-functional teams to ensure seamless execution of validation activities.
• Support audits and inspections by regulatory bodies and customers.
• Ensure compliance with industry regulations and company standards.

• Bachelor's degree in engineering (Mechanical, Biomedical, Chemical, or related field). Master's degree is an advantage.
• 2–5 years of experience in NPI and validation within a medical device or pharmaceuticals industry.
• Strong knowledge of validation principles and regulatory standards (21 CFR Part 820, ISO 13485, etc.).
• Experience with statistical tools and software (e.g., Minitab) is an advantage.
• Excellent documentation and communication skills in English.
• Detail-oriented with strong analytical and problem-solving abilities.

We offer a dynamic and challenging work environment with opportunities for growth and development. If you are passionate about quality and want to make a difference in the industry, we encourage you to apply.