1. Quality Assurance Operation
Monitor the process to ensure that the quality of products manufactured, tested, and released meets the approved specifications, GMP requirements, and applicable regulatory requirements.
Ensure compliance of In-process control activities to comply Quality System
Ensure that In-process control activities are aligned with approved procedures, validation report and qualification report.
Follow up on identified quality issues and ensure appropriate corrective and preventive actions are implemented.
Upload manufacturing formula on ERP
2. Manufacturing and Batch Documentation
Prepare and/or review manufacturing formulas and Batch Master Records (BMRs) to ensure that all activities are performed and documented in accordance the approved registered dossier.
Review completed batch records and assess batch compliance prior to final batch release.
Perform batch release activities in accordance with approved procedures.
3. Packaging and Artwork Control
Review and approve printed packaging materials and related packaging documents in accordance with approved specifications and registered dossier requirements.
Manage packaging development and artwork/design activities to ensure compliance with regulatory, quality, and product requirements.
4. Vendor Management
Manage and monitor vendor qualification and vendor-related quality activities.
Review vendor quality documentation and performance to ensure that approved suppliers consistently meet applicable quality and GMP requirements.
5. Change Control and Deviation Management
Initiate, review, evaluate, and/or approve Change Controls related to Operations, as applicable.
Evaluate deviations related Operation activities, assess their potential impact on product quality and compliance, and provide appropriate conclusions and recommendations.
6. QA Management Support and Delegation
Delegate and coordinate
QA Manager responsibilities and activities as required to ensure continuity of QA operations and effective quality oversight.
Act on behalf of the QA Manager when assigned or authorized, including supporting inspections, audits, quality reviews, and other critical QA activities.
7. Other Responsibilities
Perform other duties and responsibilities as assigned by the superior/QA Manager/QMS Director
Support continuous improvement of the Quality Management System and promote a strong quality and compliance culture within the organization.