Hikma Quality
Location
Jordan | India
Job description
• Engineers/Sr. Engineers are of two categories:
• Plants Technical & Documentation Support (Field, SOPs, Batch Records, Packaging Standards, Labeling, Incidents, Investigations, Scale Up, Audits, APRs, FAT, SAT, Mock-up, Coaching, Mentoring, Data analysis & interpretation, Protocols, Reports, Execution, )
• Plants Operation Support (Procurements, Warehouse Keeping, logistics, CAPEX, OPEX, Spare parts, Equipment Qualification/Calibration, Training follow up )
• Minimum Academic Level:
Bachelor s degree in chemical engineering or related fields.
• Job Responsibilities:
• Ensuring adherence to cGMPs, safety, quality, health and environmental procedures throughout all manufacturing activities.
• Creation, modification, reviewing and approving of Standard Operating Procedures (SOPs).
• Follow up on biennial SOP review and update.
• Creating, reviewing and approving of protocols/reports/risk assessments/comparison.
• Participating in Scale-ups designing process with R&D function.
• Participates in execution of day-to-day manufacturing activities (Production, Packaging & labeling).
• Initiating and updating manufacturing orders (MOs), Packing standards (PSs) and Block Flow Diagram (BFDs) as it comes necessary through all of the product life cycle in complete coordination with R&D and quality teams.
• Preparing the assigned process relevant investigational reports, justification, incidents, and variances, while following up on CAPAs implementation and closure.
• Initiating production APRs while ensuring that all commitments are properly made and fulfilled.
• Issuing of P.O for the production batches, applying confirmation and MIGO SAP transactions.
• Suggest modifications & development for manufacturing equipment.
• Capability of troubleshooting and properly solving the operational problems inside the production area and the related utilities
• Monitor consumables stocks and prepare a periodic list with the department needs.
• Follow up on implementation of equipment Calibration, qualification/re-qualification, and Preventive Maintenance programs.
• Follow up on six system quality internal audits observations and response while coordinating CAPAs with the concerned peoples.
• Ensure that all valves, pipes, lines & systems inside the plant are properly tagged & identified along with the layouts.
• Inspecting and reporting manufacturing area /equipment/process status on daily basis.
• Auditing and archiving of batch records/logbooks with compliance department.
• Communicate departmental operation needs with supervisor including OPEX and CAPEX items as to ensure manufacturing progression without delays or consequences.
• Training of plants team on new policies, procedural and manufacturing updates to ensure compliance prior commencing the operations.
• Follow up on plants employees training files and training schedule.
Job tags
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