Job Description
Manage the training process within the eQMS, ensuring accurate maintenance of training records and compliance with regulatory requirements.
Identify and assess training needs across departments.
Prepare, deliver, and monitor training materials and programs, including GMP and compliance-related topics.
Evaluate the effectiveness of training programs and implement improvements where necessary.
Act as a GMP subject matter expert and support the continuous improvement of training effectiveness.
Mentor and support colleagues, fostering a strong quality and compliance culture.
Oversee the CAPA (Corrective and Preventive Actions) process, including tracking, follow-up, effectiveness checks, and timely closure.
Participate in or lead CAPA-related projects, ensuring compliance, quality, and adherence to deadlines.
Compile, analyze, and report performance metrics related to CAPAs, Change Controls, and other Quality System activities.
Support continuous improvement initiatives within the Quality Management System.
Manage and maintain document control processes within the eQMS.
Support the issuance, revision, and periodic review of Standard Operating Procedures (SOPs), ensuring alignment with regulatory and corporate standards.
Ensure procedural workflows are up to date and compliant with GMP requirements.
Administer and monitor Quality Agreements with external partners, ensuring alignment with regulatory and corporate standards.
Support external audits by providing documentation, data analysis, and process insights as required.