Job Description
Responsibilities
Implement Quality Management System (QMS) processes in accordance with organizational requirements, procedures, and guidelines.
Assist in the management and follow-up of Deviations, CAPA, Change Controls, and Non-Conformities.
Review and follow up on corrective and preventive actions.
Support the execution of internal and external audits and follow up on related actions.
Prepare, review, and update Quality Management System documentation.
Record, track, and archive QMS records and documentation.
Assist in root cause investigations and analysis of non-conformities.
Follow up on overdue actions and activities and ensure their completion within the defined timelines.
Familiarity with the complaint management and investigation process, preparation of related reports, and follow-up of relevant actions.
Prepare, review, and analyze APR/PQR reports for products.
Evaluate, monitor, and rank suppliers of raw materials, packaging materials, and quality-related service providers.
Prepare reports related to Quality Management System activities.
Collaborate with different departments to ensure compliance with QMS requirements.
Participate in the improvement and enhancement of the effectiveness of Quality Management System processes.
Perform other assigned duties related to Quality Assurance.
Qualifications & Requirements
Minimum 2 years of relevant experience in QMS and Quality Assurance, preferably in the pharmaceutical industry.
Bachelor’s degree in a relevant field.
Familiarity with GMP requirements and Quality Management Systems.
Familiarity with Deviation, CAPA, Change Control, and Non-Conformity processes.
Familiarity with the complaint management and investigation process.
Proficiency in preparing, reviewing, and analyzing product APR/PQR reports.
Familiarity with the evaluation, monitoring, and ranking of suppliers of raw materials, packaging materials, and quality-related service providers.
Familiarity with internal and external audits.
Ability to prepare and control quality documentation.
Good proficiency in Microsoft Office and Excel.
High level of accuracy and attention to detail.
Strong follow-up skills and ability to manage overdue activities.
