PHARMA QUALITY HEAD

Job Description : PHARMA QUALITY HEAD KSA Job description Establish the Quality System within the organization through the implementation of Quality System elements. Lead the site Quality functions from the project stage to commercial operations. Establish and maintain the Quality Management System (QMS), including Change Control, Deviations, Investigations, CAPA, Self-Inspection, and Quality Risk Management (QRM). Establish the quality system for qualification and validation of the sterile injectable manufacturing facility. Establish and manage the site Quality Training Program. Establish and manage the Vendor Management Program. Provide guidance and methodology for qualification and validation of manufacturing and Quality Control equipment, including URS, DQ, FAT, SAT, IQ, OQ, and PQ, in compliance with regulatory requirements. Review and approve the Site Master File (SMF). Review and approve the Validation Master Plan (VMP). Review and approve Standard Operating Procedures (SOPs). Review and approve Annual Product Quality Reviews (APQR). Review and approve Standard Testing Procedures (STP) and General Testing Procedures (GTP). Review and approve all Quality Technical Agreements. Review and approve all Stability Study Programs. Support Regulatory Affairs in all regulatory submissions. Monitor Quality metrics and report performance trends to Management. Ensure compliance with Saudi FDA requirements. Host regulatory inspections at the site. Ensure implementation of analytical method transfers. Ensure the effectiveness of the Quality Management System for secondary packaging operations. Lead the recruitment of QA and QC personnel. Promote discipline and compliance within the Quality organization. Ensure adherence to Data Integrity principles. Ensure Environmental Monitoring, Media Fill, and Sterility Assurance programs are effectively implemented. Ensure timely submission of regulatory documentation and responses Promote a Quality First culture, ensuring patient safety and product quality remain the highest priority.

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