Quality Assurance Supervisor

Job Description

Responsibilities
Plan, manage, and supervise the activities of the QMS department.
Manage and prioritize ongoing and overdue activities within the department.
Supervise Deviation, CAPA, Change Control, and Non-Conformity processes.
Supervise the preparation, review, and updating of Quality Management System documentation.
Plan and oversee internal and external audits.
Follow up on corrective and preventive actions and evaluate their effectiveness.
Supervise root cause identification and analysis of problems and non-conformities.
Supervise the complaint management and investigation process, preparation of related reports, and follow-up of relevant actions.
Supervise the preparation, review, and analysis of APR/PQR reports for products.
Supervise the evaluation, monitoring, and ranking of suppliers of raw materials, packaging materials, and quality-related service providers.
Prepare and present periodic reports on QMS activities and performance indicators.
Coordinate with different departments to ensure compliance with Quality Management System requirements.
Manage and lead QMS specialists and assign responsibilities among team members.
Monitor the timely completion of activities and prevent the recurrence of overdue tasks.
Participate in the improvement and development of the Quality Management System.
Perform other assigned duties related to QMS.
Qualifications & Requirements
Minimum 5 years of relevant experience in Quality Assurance and QMS, preferably in the pharmaceutical industry.
Minimum 2 years of supervisory or managerial experience.
Bachelor’s or Master’s degree in Pharmacy, Chemistry, Chemical Engineering, Industrial Engineering, Microbiology, or other relevant fields.
Strong knowledge of GMP requirements and Quality Management Systems.
Strong knowledge of Deviation, CAPA, Change Control, and Non-Conformity processes.
Strong knowledge of internal and external audit processes.
Familiarity with complaint management and investigation processes and follow-up of related actions.
Proficiency in preparing, reviewing, and analyzing product APR/PQR reports.
Proficiency in the evaluation, monitoring, and ranking of suppliers of raw materials, packaging materials, and quality-related service providers.
Ability to manage and prioritize activities and overdue tasks.
Strong team management and leadership skills.
Strong analytical and problem-solving skills.
Ability to prepare management reports.
High level of accuracy, organization, responsibility, and follow-up.
Strong communication and interpersonal skills, with the ability to effectively collaborate with different departments.