Key Responsibilities: Quality Systems Management: Implement and maintain Good Manufacturing Practices (GMP) in compliance with regulatory requirements (e.g., WHO, USFDA, MHRA). Ensure all processes and systems meet regulatory, corporate, and client quality standards. Manage and monitor the quality management system (QMS), including change control, deviations, CAPA, and risk assessments. Documentation & Compliance: Prepare, review, and update Standard Operating Procedures (SOPs) and quality assurance policies. Conduct internal audits and coordinate external audits and regulatory inspections. Maintain and ensure timely submission of quality documentation, including batch records, validation protocols, and reports. Product Quality Oversight: Perform in-process checks during manufacturing and packaging to ensure adherence to specifications. Review and approve batch records and certificates of analysis (COA) before product release. Investigate non-conformances and implement corrective and preventive actions (CAPA). Validation & Qualification: Support validation activities for equipment, processes, and cleaning procedures. Participate in qualification of facilities, utilities, and equipment. Training & Team Collaboration: Train staff on quality-related topics, including GMP and compliance requirements. Collaborate with cross-functional teams, including production, R&D, and regulatory affairs, to ensure quality objectives are met. Regulatory Compliance: Stay updated on current pharmaceutical regulations and quality guidelines. Ensure adherence to regulatory requirements for product registrations and submissions. Qualifications: Bachelors or Master’s degree in Pharmacy or a related field. Certification in GMP, ISO 9001, or other relevant quality standards is an advantage. 2 to 4 years of experience in quality assurance in the pharmaceutical industry. Key Skills: Strong knowledge of GMP, GLP, and regulatory requirements (e.g., FDA, EMEA). Excellent documentation and analytical skills. Proficiency in quality tools and techniques, including root cause analysis and CAPA. Attention to detail and problem-solving abilities. Effective communication and interpersonal skills.
