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:
Implement and maintain QMS processes in line with cGMP and ICH guidelines
Manage documentation including SOPs, policies, and records
Handle deviations, change controls, CAPA, and risk assessments
Conduct internal audits and support regulatory inspections
Facilitate training on quality systems and GMP practices
Collaborate with cross-functional teams to ensure compliance and continuous improvement
Key Skills & Knowledge:
Solid understanding of QMS principles and pharmaceutical regulations (ICH, WHO, USFDA, etc.)
Experience in API manufacturing setting preferred
Proficiency in handling deviation, CAPA, and change control systems
Good communication and documentation skills
Knowledge of data integrity and quality risk management