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Regulatory Compliance Expert for Pharmaceutical Manufacturing
1 month ago
About the Role:
• Conduct regular audits of vendors and suppliers to ensure they meet our quality standards.
• Organize self-inspections and quality audits across various departments to identify areas of improvement.
• Collaborate with production, warehouse, and quality control teams to ensure the uninterrupted release of raw materials, intermediates, and finished products.
• Develop and implement change control procedures to address deviations and market complaints.
• Coordinate vendor questionnaires and related documentation to ensure compliance with regulatory requirements.
• Provide training to employees on GMP practices and quality implementation.
• Prepare and review process validation and equipment qualification documents to ensure accuracy and adherence to regulations.
Requirements:
• 12+ years of experience in the API/Bulk drug pharmaceutical industry.
• Proven track record of conducting customer audits and ensuring compliance with regulatory standards.
• Excellent analytical and problem-solving skills to identify and address quality-related issues.
The ideal candidate should have a strong background in quality assurance, excellent communication skills, and the ability to work independently in a fast-paced environment. We offer a competitive salary package and opportunities for growth and professional development.
