Production Lead (Only Female Candidates)

Key responsibilities

• Ensure the manufacturing activities are carried out as per the production plan in coordination with CFT departments (SCM, QA, QC, Warehouse and Engineering, Formulation Production, Regulatory Affairs…Etc.) to meet the production targets.
• Authorization of written procedures and other documents, including amendments.
• Ensure the manufacturing activities are followed according to the appropriate documentation in order to obtain the required quality.
• To approve the instructions relating to production operations and to ensure their strict implementation.
• Responsible for Preparation, Review & Indenting of Batch production record.
• Actively participate in preparation of validation protocols and to ensure the follow the instruction/procedure during validation exercise.
• To ensure that production records are evaluated and signed by an authorized person before they are sent to the QA department.
• To ensure the monitoring of compliance with the requirements of cGMP.
• Responsible for participating in Internal Audit, Customer Audits and Regulatory Audits and to ensure no critical and Major observations.
• Responsible for Handling of Nichelon 5 CMS software as user, reviewer and Approver.
• Responsible for Handling of Change controls and CAPA’s.
• Responsible for Handling of Out of Specification (OOS), Out of trend (OOT), Deviation, Incidents and Market compliant investigations.
• Responsible for handling of Nichelon, Nice label Software, BIMS, QAMS and DMS applications.
• To co-ordinate with R & D and TTD departments during the execution of Development, Exhibit, Experimental and validation batches.