Quality Leadership and Computer System Governance
Main Purpose and Objectives:
* Provide Quality Direction: Offer leadership, guidance, and governance for assigned areas of responsibility.
* Manage Quality Matters: Oversee quality-related matters within specific domains.
* Approve Documentation: Ensure compliance with internal policies and GMP requirements by approving relevant quality-related documentation.
* Maintain Control Systems: Establish, maintain, and manage control systems for assigned areas, including training personnel.
Key Responsibilities:
1. Computer System Quality & Compliance:
* Maintain Compliance: Ensure full compliance with GMP and computer system quality (CSQ) requirements.
* Provide Oversight: Provide oversight, guidance, and approval for computer-related validation documentation.
* Lead Training Initiatives: Lead training initiatives to ensure personnel are equipped with knowledge of computer system quality standards.
* Support Standardized Procedures: Support the development and implementation of standardized local procedures for computer systems.
* Escalate Critical Issues: Escalate critical quality issues to management levels for resolution.
* Participate in Cross-Functional Meetings: Participate in cross-departmental meetings and forums to promote consistency in quality practices.
Required Skills and Qualifications:
* Education Requirements:
o A Bachelor's, Master's, or Ph.D. in Chemistry, Engineering, or a related discipline is required.
* Technical Expertise:
o Familiarity with computer system quality standards and regulations.
o Knowledge of GMP requirements and quality management principles.