Manager Quality Assurance For Kampala Uganda Plant

Role & responsibilities

• To Approve Specification, Standard Test Procedures for Raw material, Packing material and Finished product.
• Conducting training an cGMP, SOP and other subject such as Safety, Plant Hygiene and other subjects.
• Preparation, Review and Approval of Standard Operating Procedure (SOP) related to the Quality System.
• Preparation, Execution and Approval of Protocol and Reports for Cleaning Validation activity.
• Review and Approval of Process Validation / Hold Time Study Protocol and Reports.
• Preparation, Review & Approval of Site Master File (SMF), Validation Master Plan (VMP) and Quality Manual.
• To perform and Supervise regular Self-inspection as per the schedule and verifying the compliance.
• Preparing the Protocols, Review, and Execution and Approval of Qualification of area, Equipment and Utility.
• Preparation, Execution, Review and Approval of Protocol and Report of HVAC, Purified Water and Compressed Air Validation activity.
• Release of Finished Goods for Sale.
• Approval of Change Control proposal, Deviation, Return Goods & RM/PM Rejection.
• Preparation, review & approval of Annual Product Quality Review Reports.
• Approve Release of Batch Under Quarantine.
• Review and Approve the QRM the QRM Document prepared and monitor of the same.
• To Perform, Approve and Monitor Vendor Audits of API, Excipients / Primary / Secondary packing Materials and other Supplier providing Technical Services. Review and Approval of QRM for Excipients.
• Handling Technology Transfer from various MA Holder agency, Interaction and Handling Competencies as per Technical Agreement.
• Investigate, Review and Approve the Reprocessing and Reworking, wherever applicable take Approval from Regulatory Agency and MA Holder.
• Review and Monitoring of Control samples, Annual Physical Verification, Destruction and Document pertaining to it.
• Preparation, Review of Management Review Report (MRR), Presentation to Senior Management as per Frequency.
• Notification of Critical Observation either in-house or from external agency to Senior Management/ Regulatory Agency / MA Holder, case to case basis.
• To Perform annual Trending of different QMS System and evaluate the same.
• Control on Document and Data Pertaining to QMS system. Review of activities with respect Data Integrity.
• To evaluate Batch Records.
• To perform Audit & Approval of Contact laboratory.
• Investigation in case of Incident, Market complaint, Product Recall, Return Goods, Redressing, Out of Specification / OOT or any other factor that may affect product quality.
• To perform Investigation, Root cause analysis and Implementation of Corrective Action and Preventive Action (CAPA) and Monitoring its Effectiveness time to time.
• Establishment, Implementation & Maintenance of Quality system.
• Review & Approval of the Quality Documents.
• Preparing the Response & Report for Various External Audits.
• Monitoring and Control of Manufacturing Environment.
• Evaluation of In process Controls.
• To ensure all necessary testing carried out.
• Retention of Records.
• Monitoring Compliance of GMP requirement.
• To Reject the Finished product not complying to laid down Finished Product Specification.
• Approval of BMR & BPR.
• Ensure compliance of GMP in all six system & co-ordinate with each dept. Head for implementation & monitoring of compliance to SOP's.
• To ensure Calibration of Analytical Apparatus & Measuring Devices as per Schedule.
• Administrative & Functional Reporting to Managing Director.
• To perform the periodic review of electronic data and user privileges in QC Department
• To ensure that the quality of the pharmaceutical products are fit for their intended use, comply with the requirements of the license and do not place patients at risk due to inadequate safety , quality or efficacy .