KEY RESPONSIBILITIES AND DUTIES:
1- Management of In-process control Process
a. Supervising operators during the in-process control, assuring the process flow according to GMP rules & monitor their capability, performance & enhance it through training & motivation.
b. Check the recording in the IPC devices logbooks daily.
c. Check the calibration & cleaning of IPC devices to ensure compliance with GMP standards & guidelines Assuring the validity of measuring and controlling devices (balances, IPC Instruments)
d. Report deviations related to process and participated in the investigation as relevant and ensure optimum communication with Production team and QA team.
e. Prepare & implement plans for technical training of both newly hired & existing staff to enhance performance especially in areas of GMP concepts, HSE & SOP system.
2- IPC Documentation Management:
a. Updating / creating SOPs & supervise implementation of SOPs by all workers.
b. Creating / Updating Logbooks .
3- Calibration / Qualification Plan.
a. Prepare the yearly calibration / qualification plan for IPC Equipment.
b. Perform the calibration and Qualification activities in house as relevant.
c. Follow up the implementation and organization with local calibration team / external suppliers for on time calibration / Qualification of IPC Equipment.
4- IPC Capex:
a. Assess the need for CAPEX for IPC department based on the long-term plan to ensure the availability of needed Equipment for testing.
b. Prepare URS / Get offers follow the purchase of equipment till delivery and qualification.
5- Make annual plan for providing the department with process consumables (labels, stationary tools ...etc.) and perform the role required in the procurement process.
6- SMS Activities:
a. plan for the process improvement such as increasing productivity, capacity, optimizing use of resources etc.
b. Share in the lean and other industrial activities.
7- Tablet compression sets Management:
a. Ensure there is a system for management of tablets compression machine punches and dies, including recording of use in logbooks and inspection before and after use.
b. Ensure there is a process for periodic checking of punches to identify the need for repair / or Replacement and ensued the optimum usage and lifetime.
8- Working as Second Line for Solids and manufacturing areas and Dispensing Area
9- Responsible of Procurement activities through managing all OPEX & CAPEX for NS-production unit.
HSE & Energy Role:
1. Applying the machine safety checklist on regular basis.
2. Ergonomics training on regular basis.
3. Commitment to the appropriate PPE use
4. Ensures that risk assessment to any new transferred product and new machine is adequately covered.
5. Continuous monitoring to the first aid boxes
6. Executing waste management measures for optimum utilization of resources.
7. Follow the approved HSE policy and requirements.
8. Follow all the statutory legalization concerning Health, Safety and environmental law.
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