Karim Alawady

QA IPC

• Job Details:Check and follow up on all production manufacturing steps (weighing of raw materials, preparation, filling, and packing). Preparing the standard operating procedures (SOPs) under supervision of IPC section head. Performs complex inspection and sets quality standards for both in-process and finished products and materials. Develops methods for testing, sampling, and training; evaluates production and recommends improvements. Follows up on deviations and establishes corrective action plans. Supervises the implementation of cGMP during manufacturing steps. Conducts physical examinations during manufacturing and for finished products. Participated in internal and external audits, including two WHO inspections specifically in cephalosporin sterile production area, Romanian regulatory authority audit, African regulatory audit, Egyptian Drug Authority (EDA) inspection. Supported data integrity and documentation compliance according to ALCOA+ principles. Contributed to validation processes for sterile manufacturing equipment and cleanroom qualification. Provided technical support during troubleshooting of production deviations and batch failures. Trained new IPC team members on documentation procedures and quality check protocols. Collaborated with cross-functional teams (production, QC, maintenance) to ensure GMP compliance and reduce downtime.