Senior Quality Assurance Officer, MBA Student
Benta Pharma Industries
Total years of experience :14 years, 0 Months
Responsible for maintaining the quality system documentation.
Handling all quality assurance activities as per policies and procedures.
Ensuring that the quality system is well respected and maintained in conformity with ISO 9001 and Good Manufacturing Practices standards.
Managing deviations, out of specifications, change controls, complaints and improvement actions and following up the action plan set after investigation.
Preparing complaints to be sent to suppliers.
Preparing the Annual Internal Audits (ISO & GMP) Plan and following them yearly with internal auditors.
Conducting internal audits as per the audit plan.
Preparing internal audits reports.
Assisting in External Audits and following up the action plan set after their conduction.
Preparing the internal Annual Training Plan and following it up with concerned trainers.
Writing and re-evaluating Quality Assurance documents.
Ensuring that all the units’ documents are re-evaluated on time.
Reviewing the units’ documents before final approval of the Quality Assurance Manager.
Ensuring that the self-inspection and the end of month reports are respected by all the concerned units.
Preparing the management review meeting.
Preparing the Annual Product Review.
Performing trainings (ISO 9001, GMP, Procedures, working instructions…).
Responsible for maintaining the quality system documentation.
Handling all quality assurance activities as per policies and procedures.
Ensuring that the quality system is well respected and maintained in conformity with ISO 9001 and Good Manufacturing Practices standards.
Managing deviations, out of specifications, change controls, complaints and improvement actions and following up the action plan set after investigation.
Preparing complaints to be sent to suppliers.
Preparing the Annual Internal Audits (ISO & GMP) Plan and following them yearly with internal auditors.
Conducting internal audits as per the audit plan.
Preparing internal audits reports.
Assisting in External Audits and following up the action plan set after their conduction.
Preparing the internal Annual Training Plan and following it up with concerned trainers.
Writing and re-evaluating Quality Assurance documents.
Ensuring that all the units’ documents are re-evaluated on time.
Reviewing the units’ documents before final approval of the Quality Assurance Manager.
Ensuring that the self-inspection and the end of month reports are respected by all the concerned units.
Preparing the management review meeting.
Preparing the Annual Product Review.
Performing trainings (ISO 9001, GMP, Procedures, working instructions…).
• Formulation and trials development.
• Assisting Production Manager in all duties, and delegated for signing Batch records, Specifications and mock ups.
• Representing the Production Manager in the audits meetings.
• Preparing the monthly production planning and coordinating with logistics.
• Preparing all validation documents (protocols & reports) of pharmaceutical products.
• Preparing all technical support data requested by the DRAU for registration file (process flow, formula, material balance, part 3.2.P. of the common technical data).
• Preparing and review batch records and internal printing process.
• Preparing some trials before going to Production scale batches.
• Supervising Processing and packaging employees when requested, and performing the line clearance and cleanliness.
• Performing the monthly self inspection on Production.
• Ensuring the records of the production job timescale and the production batch assessments.
• Writing, reviewing, reevaluating and modifying all necessary documents related to production process.
• Preparing the master file for each product produced.
• Setting up the training schedule, presentation and training the production staff and the university students.
• Maintaining the qualification schedule of apparatus updated and ensuring the performance of their qualification on time.
• Coordinating with other departments especially the QA, QU and Logistics and ensuring the good implantation of the GMP and ISO requirements.
• Managing all deviations, change controls and IAF’s related to Production.
• Writing the end of month reports and the monthly Processing and Packaging assessments.
• Preparing and conducting all internal audits done by Production on all the other departments (certified internal audit).
• Member of the change control committee and the internal auditors of the company, representing the Production department.