Quality System Support: Assist in the development, implementation, and maintenance of the quality management system (QMS).

Ensure compliance with relevant regulatory requirements, including FDA, EMA, and other global agencies.

Documentation Control: Manage document control processes, including document creation, review, approval, distribution, and archival.

Maintain and update quality documents, standard operating procedures (SOPs), and records.

Audits and Inspections: Support internal and external audits, inspections, and assessments by regulatory authorities or third-party organizations.

Coordinate audit preparations and responses, ensuring timely closure of audit findings.

Training and Compliance: Provide training on quality procedures and ensure that employees are knowledgeable and compliant with established quality standards.

Monitor and track compliance metrics.

Non-Conformance Management: Investigate and assess non-conformances, deviations, and incidents.

Collaborate with cross-functional teams to implement corrective and preventive actions (CAPAs).

Risk Management: Assist in risk assessments and risk management activities.

Identify and assess potential risks and recommend mitigation strategies.

Continuous Improvement: Participate in quality improvement initiatives and projects to enhance processes and systems.

Promote a culture of continuous improvement and quality excellence.

Quality Reporting: Prepare and maintain quality reports, metrics, and key performance indicators (KPIs).

Communicate quality performance to management and stakeholders.

Qualifications:

• Bachelor's degree in a relevant scientific field, life sciences, or related discipline.
• Experience in quality assurance or quality control within the pharmaceutical, biotechnology, or rare disease industry
• Strong knowledge of regulatory requirements (FDA, EMA, ICH) and quality standards.
• Excellent attention to detail, analytical, and problem-solving skills.
• Proficiency in document control and quality management systems.