Quality Assurance Senior Officer

Job Summary

Support Quality system processes and maintain quality assurance standards and compliance with GMPs.

Duties And Responsibilities

Audit and review production batch records before each production stage and after the end of the production process to ensure compliance with GMPs and company SOPs. Provide guidance to production employees on machine capacity and operation. Ensure that readings of pressure differences, temperature and humidity inside the plants are within the allowed limits and coordinate with Utilities for plant qualifications with respect to temperature, humidity and pressure differences. Coordinate and follow up on CAPA, OOS, deviations, nonconformance and investigations. Log received deviations under the supervision of the QA Supervisor or his delegate. Coordinate with Maintenance regarding matters of preventive and corrective maintenance. Assist with the preparation of failure investigations by collecting data and checking retained samples. Assist with revising and developing SOPs. Maintain documentation for materials to be destroyed and give consent to initiate the process. Review and archive documents in compliance with good documentation practices. Train new staff on any changes in the system. Prepare summaries related to all QA activities (failure investigations, self-inspection, reprocessing evaluation and change control requests) Coordinating with the Regulatory Affairs Department to follow up on the registration matters for the validity duration of the product (Shelf Life) related issues for each country. Coordinating with Quality Control Department (chemical analysis supervisor) and the Microbiology Department to coordinate the analysis functions and the product batches' size and number and to find out the results of the analytical tests. Tasks assigned by the Quality Assurance supervisor or his delegate and manager related to QA officers' tasks follow up . Handling the deviation management system. Handling critical work maintenance system. Follow and check the BMS system. Handling the supplier complaint system. Checking the BMR before the final release.

Professional Knowledge

ICH, GMP, GLP, WHO, FDA, EMA, MOH ISPE Guidelines Production Area Layout Design Trend Analysis Statistical Analysis Documentation Control Systems Good Documentation Practices Systems Development and Workflow Failure Investigations Tracking Systems

Main Competencies

Demonstrate excellent analytical skills, able to plan, organize and follow up work effectively while focusing on quality towards excellence. Strong team player with excellent communication skills Proactively take initiatives and demonstrate a dynamic approach to adapt with changing business needs and environment

Job Requirements

BSc. Degree in Pharmacy, Chemical Engineering, Chemistry or equivalent. Minimum 2 years of experience in a GMP Quality Assurance / Compliance environment. Fluent in Arabic and English languages.

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