The role
0301Support the Sr. Manager QA in all quality related activities within a GMP-regulated environment.
02Ensure the timely review of batch documentation and associated analytical results, and perform the final status assignment or rejection of intermediate and finished products.
03Review, assess, and approve quality-related documents (e.g. manufacturing instructions, analytical procedures, validation and qualification documentation, and Certificates of Analysis (CoAs).
04Ensure compliance with applicable GMP requirements and actively contribute to the continuous improvement of the Quality Management System (QMS).
05Review and manage deviations, change controls, CAPAs, and customer complaints in accordance with internal procedures and regulatory requirements.
06Support the preparation, execution, and follow-up of customer, supplier, and regulatory authority audits.
07Plan, perform, and ensure the timely execution of environmental monitoring (re-) mapping studies, including the evaluation, documentation, and reporting of study results.
