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Job Description
- Leads sterile production including processing and packaging operations.
- Provides direct supervision on all process steps : Materials preparation Formulation - Sterile filtration and filling - Terminal sterilization - Automatic inspection - Labeling and finally automatic packaging operations .
- Ensures day to day implementation of GMP and HSE guidelines within sterile production unit.
- Provides training sessions and OJT for new pharmacists as well as new process operators.
- Day to day monitoring of critical process parameters and critical steps during sterile operations.
- Direct supervision of annual qualification and calibration for sterile production equipments in collaboration with engineering.
- Leading annual sterile gowning qualification for sterile operators.
- Issue and lead the investigations of sterile production deviations ,performing root cause analysis and setting appropriate CAPA
- Participate in passing Global quality audits successfully and audit points action plan closure.
- Issue and update production SOPs .
- Managing change control inside sterile production.
- Managing sterile process validation activities.
- Participation in new equipment qualification (Installation / Operation /performance qualification)
- Performing sterile production GAP analysis and setting remedial action plans .
- Update and review production master batch records.
Job Requirements
- Bachelor in Pharmaceutical Science.
- 2-5 years of experience in the same position.
