Job Description
Mail:- [Confidential Information]
Pharmaceutical Quality Assurance (QA) professional ensures that drugs are manufactured, tested, and released in strict compliance with Good Manufacturing Practices (GMP) and regulatory standards, focusing on process oversight to ensure product quality. Key responsibilities include managing batch release, auditing processes, handling deviations, conducting risk assessments, and maintaining documentation to guarantee patient safety.
Lab ManagerLab Manager +4Key ResponsibilitiesBatch Record Review & Release: Review manufacturing/packaging records for compliance, ensuring batch final disposition.GMP Compliance & Auditing: Perform internal and external audits to ensure compliance with cGMP and regulatory guidelines (FDA, EMA).Deviation and CAPA Management: Investigate deviations, non-conformances, and market complaints, implementing Corrective and Preventive Actions (CAPA).Change Control & Documentation: Manage the change control system (materials, equipment, processes) and approve SOPs, protocols, and reports.Validation & Qualification: Oversee equipment qualification, process validation, and cleaning validation activities. Lab ManagerLab Manager +7Required Skills and QualificationsEducation: Bachelor's or Master's degree in Pharmacy, Chemistry, or Life Sciences.Knowledge: Deep understanding of cGMP, ICH guidelines, and regulatory requirements.Skills: Strong attention to detail, analytical troubleshooting (root cause analysis), communication, and documentation skills.Experience: Previous experience in a pharmaceutical quality role is typically required. Innopharma EducationInnopharma Education +4Common QA Roles
