Quality Head
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Key skills for this role
About the Role
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.
Key Skills for This Role
Responsibilities
- Establish the Quality System within the organization through implementation of Quality System elements
- Lead site Quality functions from project stage to commercial operations
- Establish and maintain the Quality Management System (QMS) including Change Control, Deviations, Investigations, CAPA, Self Inspection, and QRM
- Establish quality system for qualification and validation of sterile injectable manufacturing facility
- Establish and manage site Quality Training Program and Vendor Management Program
- Provide guidance for qualification and validation of manufacturing and QC equipment
- Review and approve Site Master File, Validation Master Plan, SOPs, APQR, STP, GTP, and 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 and host regulatory inspections
- Ensure implementation of analytical method transfers and effectiveness of QMS for secondary packaging
Requirements
- Extensive experience in pharmaceutical quality management
- Experience with sterile injectable manufacturing
- Knowledge of Saudi FDA requirements
- Experience in leading QA and QC teams
- Expertise in validation and qualification (URS, DQ, FAT, SAT, IQ, OQ, PQ)
Full Job Posting
Overview
- 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.
Responsibilities
- 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.
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