We are seeking a dedicated QMS professional to oversee and maintain the Quality Management System in compliance with cGMP and regulatory requirements. The role involves managing documentation, handling quality events, and supporting internal and external audits in an API manufacturing workplace.
Key Responsibilities:
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Implement and maintain QMS processes in line with cGMP and ICH guidelines
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Manage documentation including SOPs, policies, and records
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Handle deviations, change controls, CAPA, and risk assessments
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Conduct internal audits and support regulatory inspections
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Facilitate training on quality systems and GMP practices
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Collaborate with cross-functional teams to ensure compliance and continuous improvement
Key Skills & Knowledge:
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Strong understanding of QMS principles and pharmaceutical regulations (ICH, WHO, USFDA, etc.)
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Experience in API manufacturing environment preferred
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Proficiency in handling deviation, CAPA, and change control systems
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Good communication and documentation skills
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Knowledge of data integrity and quality risk management