Quality Assurance Officer

Description:

Bachelor's degree in Pharmacy, Biotechnology, Life Sciences, or a related field.
Minimum of 2 years in Quality Assurance within the medical devices or pharmaceutical industry.
Develop, implement, and maintain QMS in compliance with local and international regulations (e.g., ISO 13485, GDP). Regularly review and update Standard Operating Procedures (SOPs).
Ensure documentation control and record-keeping for all quality- related activities.
Monitor compliance with Good Distribution Practices (CDP) and Good Manufacturing Practices (GMP).
Conduct internal audits to ensure compliance with QMS, SOPs, and regulatory requirements.
Prepare for external audits and regulatory inspections. Address audit findings with corrective and preventive actions (CAPA).
Maintain audit records and ensure timely resolution of non- compliance issues.
Conduct quality training programs for staff on SOPs, QMS updates, and regulatory changes.
Ensure personnel are aware of quality and safety standards.