Job
Description
You will be responsible for the following key areas in the role of Quality Management System: Role Overview: You will be responsible for the preparation, revision, review, and harmonization of SOPs, Protocols, Quality system policy, Quality manual, and Guidance documents at CQA to simplify procedures and improve practices across different sites of Alkem and Corporate functions. Additionally, you will manage the publishing, issuance, retrieval, and distribution of documents (SOP, Format, Guidance documents, and Quality system policy) through eDMS. Key Responsibilities: - Initiate and review Global CAPA activities, including actions initiated at manufacturing sites and corporate functions of Alkem. - Conduct GAP assessment of GMP trends, US FDA483s observations, and internal/external quality events to identify Global CAPA(s) for evaluation and implementation. - Review and maintain global CAPA/CAPA tracking and verification processes. - Ensure closure and implementation of Global CAPA. - Coordinate training activities as the CQA training coordinator, handling e-TMS (Electronic Training Management System). - Provide training to new joiners on CQA induction modules. - Review CQA and other corporate function SOPs, Quality system policy, and Guidance documents during training sessions. Qualifications Required: - Proficient in handling SOPs, Documents, and Quality system policies. - Experience in managing Global CAPA activities and conducting GAP assessments. - Familiarity with regulatory updates and gap analysis procedures. - Strong coordination and training skills. (Note: No additional details of the company were mentioned in the provided job description) You will be responsible for the following key areas in the role of Quality Management System: Role Overview: You will be responsible for the preparation, revision, review, and harmonization of SOPs, Protocols, Quality system policy, Quality manual, and Guidance documents at CQA to simplify procedures and improve practices across different sites of Alkem and Corporate functions. Additionally, you will manage the publishing, issuance, retrieval, and distribution of documents (SOP, Format, Guidance documents, and Quality system policy) through eDMS. Key Responsibilities: - Initiate and review Global CAPA activities, including actions initiated at manufacturing sites and corporate functions of Alkem. - Conduct GAP assessment of GMP trends, US FDA483s observations, and internal/external quality events to identify Global CAPA(s) for evaluation and implementation. - Review and maintain global CAPA/CAPA tracking and verification processes. - Ensure closure and implementation of Global CAPA. - Coordinate training activities as the CQA training coordinator, handling e-TMS (Electronic Training Management System). - Provide training to new joiners on CQA induction modules. - Review CQA and other corporate function SOPs, Quality system policy, and Guidance documents during training sessions. Qualifications Required: - Proficient in handling SOPs, Documents, and Quality system policies. - Experience in managing Global CAPA activities and conducting GAP assessments. - Familiarity with regulatory updates and gap analysis procedures. - Strong coordination and training skills. (Note: No additional details of the company were mentioned in the provided job description)
