-Issuing technical documents such as SOPs, deviations, change controls, training documents, internal external audit reports, complaint & recall reports.
- Training and documents related to DC system and bill of materials.
-Maintaining the documentation system as per cGMP requirements and ensure document control on periodic basis to QA Manger to review and sign it.
- Handling of customer complaints which includes assessing the complaints, determine rating, coordination and facilitation of investigation report till reaching root cause and approval of corrective actions if needed.
-Administer and coordinate of GMP internal audits including developing, coordination of audit schedule, identify audit team members, prepare perform and conduct audit
- handling of deviations and CAPA
-Prepare and draft Quality Management System procedures for further approval
-Supervise and authorize the distribution, archival, retention and destruction of controlled documents according to internal procedures.
-Handling of change control process including assessment of change control, follow up and track required actions until implementation.
B.Sc Of Science. Proven work experience not less than two years as a QA compliance specialist.● Working knowledge of tools, methods and concepts of quality assurance● Solid knowledge of relevant regulatory standards● Good communication skills, both verbal and written● Excellent data collection and analysis skills