Job Description:
Establishes a reporting environment that ensures objective and impartial audits
Qualifies auditors (knowledge, experience, and skills) and calculate the required resources to achieve the management objective
Establishes controls (procedures, criteria, plans, and objectives) for an effective and efficient audit program
Creates, distributes, and maintains audit program schedules (internally and externally according to the management and business needs)
Determine the external and internal issues, risks, and opportunities that can affect the audit program, and implement actions to address them, integrating them in all relevant auditing activities.
Establish all relevant processes including processes for:
- The coordination and scheduling of all audits within the audit program
- The establishment of audit objectives, scope(s) and criteria of the audits, determining audit methods and selecting the audit team
- Evaluating internal auditors for completing auditor qualification program
- The establishment of external and internal communication processes
- The resolutions of disputes and handling of complaints
- Audit follow-up if applicable
- Reporting to the audit client and relevant interested parties, as appropriate.
Ensuring that the follow-up on the audit responses in carried out and the Audit process timelines is maintained (reporting and communication)
Reviewing the Audit plan for all the conducted audit, determine what will be the type of the audit , ensure that the Audit basis is there and the Lead auditor Experience and background match the scope of the audit and to Monitors auditor performance
Ensuring the selection of audit teams and the overall competence for the auditing activities by assigning roles, responsibilities, and authorities, and-supporting leadership,
Ensure that appropriate documented information is prepared and maintained, including audit program records.
Training for the Co Auditors and coaching
Ensure that the audit reports and distribution/circulation to the vendors and track the vendor's CAPA responses for closure on due dates with supportive evidence
Reports audit program progress to management through Monthly evaluation of internal and external audit reports closed-out and pending actions for KPI and Quality Council Information.
To Perform a full system review and revisit the Auditing plan on an annual basis.
Support the improvement of the quality management system using quality tools.
Approve all the AMS-related records on the EQMS system.
Lead and manage the inspection readiness program for the RAK site.
Maintaining the inspection readiness form in RAK site.
Support the business development and company objectives
Ensures the confidentiality of the audit program and maintains the 2nd parties data
Promotes ethical behavior on the part of auditors and those involved in managing the audit program
Managing site audit preparation will relevant stakeholders
Support in the preparation for all logistics of onsite audit and ensure the audit cycle compilation
Qualifications:
Bachelor’s degree in pharmacy. A Master’s degree or higher qualification is preferred.
A minimum of 10 years of experience in quality management within the pharmaceutical industry preferably in Quality Management systems, and proven experience in Audit management
In-depth knowledge of GMP, FDA regulations, and other relevant regulatory standards.
Proficient in MS Word, Excel, and PowerPoint
Professional certification (e.g., ASQ Certified lead auditor) is a plus.
Core Competencies:
Professional knowledge in Quality Management systems
Technical Background related to the GMP areas and strong knowledge about the Regulatory standards and audit basis.
Completed the Auditor Qualification program
Ethical and adheres to an organization code of conduct and complies with the principles of auditing as listed in ISO 19011, section 4
Risk-Based Approach
Process management
High on Accountability & Ownership
Good Communication skills and presentation skills
Solid knowledge about the Quality improvement tools and continuous improvement frameworks
High on business acumen, having a strong understanding and practice of 'cost consciousness'
Excellent in Result & Process Orientation for self and department achievement
High on adaptability and change management skills
High on resolution mindset with good decision-making skills
Excellent team building, strong time and task management for self and team