Production Quality Assurance Compliance Officer

• Ensure timely preparation, review, and approval of all quality reports within departmental deadlines.
• Lead, create, and review process investigations and risk assessment documents, ensuring thorough documentation and implementation of appropriate corrective actions.
• Initiate, investigate, and manage compliance documentation including Change Controls, Deviations, SCARs, Reject Notices, and CAPAs.
• Conduct routine quality audits within the department to verify compliance and proactively address any emerging issues.
• Develop and update Quality Procedures, including Standard Operating Procedures (SOPs), in alignment with current GMP regulations.
• Drive continuous improvement initiatives to enhance the company's Quality and GMP standards, with a focus on strengthening the overall quality system.
• Support and, when required, lead quality-related projects within the department, collaborating effectively with multidisciplinary teams.
• Participate in self-inspections, internal audits, and regulatory inspections, ensuring timely implementation of corrective actions.
• Contribute to Change Control meetings and actively participate in monthly Quality Management & Review meetings.
• Perform any additional duties as assigned by the responsible Production Manager.

• Bachelor's degree in a quality or science-related discipline.
• Lean/Six Sigma certification and statistical analysis knowledge are highly desirable and considered advantageous.
• Minimum of 4-5 years' experience in a GMP-regulated manufacturing environment, with a strong working knowledge of EU GMP and US FDA guidelines.
• Prior experience in the pharmaceutical industry is preferred; however, relevant experience in the medical device sector will also be considered.
• Strong report writing skills and proficiency in IT systems.
• Proven hands-on experience in delivering a best-in-class Quality Assurance function in a similar role.

• Excellent communication and interpersonal skills, with the ability to engage effectively across all levels.
• Strong analytical, methodical, and structured approach to work organization and problem-solving.
• A proactive mindset focused on process improvement and operational excellence.
• Proven ability to manage multiple high-priority tasks simultaneously in a fast-paced environment.
• Exceptional team player with the capability to collaborate with and influence multiple stakeholders.
• Demonstrates flexibility, a strong willingness to learn, and a commitment to going the extra mile.

Chanelle Pharma