JOB DETAILS:
Quality Chemical Industries Limited (Qcil). is the largest pharmaceutical manufacturer in East Africa and one of the largest in Sub-Saharan Africa (SSA). Qcil is a World Health Organization (WHO) CGMP compliant facility that manufactures antiretrovirals, artemisinin-based combination therapies (ACTs) and, Hepatitis medicines, to treat HIV/AIDS, Malaria, and Hepatitis respectively.
We seek to recruit a dynamic, competent. experienced, and professionally confident individual, who is also a committed team player to strengthen our staff capacity by filling the following vacant position.

Job Summary:
The Lead Audit Management will oversee and coordinate all cGMP and ISO 9001 audit activities within the plant. This role involves strategic planning, execution, and continuous improvement of audit processes to ensure full compliance with regulatory requirements. industry standards, and company policies. The position will play a critical role in maintaining the highest standards of quality and compliance, aligned with both cGMP and ISO 9001 guidelines.

Key Responsibilities:
• Develop and implement annual internal and external audit plans in alignment with cGMP. ISO 9001, and regulatory requirements.
• Lead the execution of audits, ensuring adherence to SOPs and timely reporting of findings with recommendations for corrective actions.

• Oversee CAPA implementation and monitor effectiveness, escalating critical issues to senior management.
• Conduct audits of external suppliers and contractors, ensuring compliance with Quality Technical Agreements (QTAs).

• Maintain and present detailed records of audit activities, findings, and risk assessments to senior management.

• Provide training and mentorship to audit teams, fostering a culture of continuous improvement and compliance.

Qualifications, Skills and Experience:
• Bachelor's Degree in Pharmacy, Industrial Chemistry, or related field
• Certificate in cGMP Quality Auditing or ISO will be an added advantage

• 7+ years' experience with proven leadership experience in managing audit teams and complex audit projects
• In-depth knowledge of CGMP and ISO 9001 standards
• High analytical mind, with exceptional problem-solving skills and attention to detail

• Ability to work independently and collaboratively in a team environment
• Excellent communication skills, both oral and written.