مدير فني

Detailed Job Description:

Main Responsibilities:

1. Technical & Quality Leadership

• Manage all technical- related functions and departments within the plants as per the SFDA Guidelines.
• Final approval of suppliers of semi-finished/ Raw Material and packaging materials, technical agreements for outsourcing activities and all changes of building, utilities, production lines and products variation
• Oversee the implementation, monitoring, and continuous improvement of the Quality Management System (QMS).
• Review and approve critical quality and technical documentation (e.g., Site Master File, Quality Manual, Validation Master Plan).
• Approve process validation, equipment qualification, and change control activities.
• Authorize investigations related to deviations, out-of-specifications (OOS), and product complaints.
• Manage product recall processes and ensure proper documentation and corrective actions.
• Final approval of the organogram and the job description.

2. Regulatory & Compliance

• Ensure full adherence to cGMP, GLP, GDP, and SFDA regulatory requirements.
• Responsible for representing the plant during the SFDA inspection along with the QA.
• Approve responses and CAPA plans related to internal, external, and regulatory audits.
• Oversee management of controlled and narcotic substances in compliance with Saudi regulations.
• Ensure accuracy and completeness of all technical documents submitted for product registration and renewal.
• In Case of Recall, Responsible to manage the investigation the Recall Process in coordination with the QA department.

3. Operational & Strategic Management

• Approve supplier/vendor qualifications for raw materials, packaging materials.
• Ensure proper execution of technology transfer and product lifecycle management activities.
• Conduct internal audits and management reviews to assess QMS performance and drive continual improvement.

4. Leadership & Staff Development

• Define roles, responsibilities, and performance expectations for technical staff.
• Identify competency gaps and implement training and development programs.
• Evaluate employee performance and promote a culture of accountability, quality, and safety.
• Foster effective communication and collaboration across technical and quality functions.

5. Additional Duties:

• Prepare and present technical and operational performance reports for senior management.
• Support external audits, inspections, and regulatory visits.
• Perform any other job-related duties as assigned in line with business needs.
  

6. Environmental, Health and Safety Responsibilities:

• Follow the company’s Environmental Management System (ISO 14001:2015) and HSE policies in daily work.
• Follow and ensure compliance with Saudi Safety Guidelines like, NCOSHA, SASO, OSH, NEBOSH,
• Actively minimize environmental impacts, maintain a safe workplace, and handle tasks responsibly (e.g. proper disposal of waste, safe use of equipment).
• Report hazards, non-conformities, or environmental issues to supervisors and support continual improvement initial.

Core Competency:

• In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
• High compliance adherence, having strong diligence, initiative-taking, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Having demonstrated skills in leadership and people management
• Motivated, organized, focused & overall compliance.
• Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
• Identify, reduce, and prevent environmental impacts and operational risks.
• Contribute to EHS activities, audits, and continual improvement initiatives.

Qualification/Functional Knowledge:

• Education: Bachelor’s or Doctorate degree in Pharmaceutical Sciences / Pharmacy (B.Pharm or PharmD) – mandatory as per SFDA regulations
• Experience: Minimum 10 years in pharmaceutical manufacturing, quality assurance, or related technical fields, including leadership experience in a cGMP-regulated environment, with minimum 5 years of Similar Role
• Comprehensive understanding of GMP, GDP, ISO 9001 and ISO 14001 requirements.
• Strong familiarity with regulatory guidelines (e.g. SFDA, FDA, WHO, EU).
• Experience in audits, CAPA, risk management, and QMS systems.
• Excellent leadership and team management skills.
• Analytical thinking and problem-solving skills.
• Proficiency in MS Office and electronic QMS platforms