Quality Assurance Specialist

Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Manager to join our organization. The successful candidate will be responsible for maintaining a satisfactory and good environment in production, warehouse, maintenance, and marketing according to GMP and GLP standards.

Key Responsibilities:

• Maintain a smooth working and technical environment in quality control.
• Authorize the release or rejection of raw materials, packaging materials, in-process products, and finished products on valid grounds.
• Review and monitor objectives on a regular basis and revise them as needed.
• Evaluate the laboratory's capabilities to perform tests according to specifications and standards.
• Be responsible for all purchases made in the laboratory, including requisitions with specifications for reagents, equipment, glassware, chemicals, and microbiological articles.
• Ensure that bulk samples of chemicals and glassware are stored by the material management department under agreed-upon conditions and verified by the quality assurance manager.
• Evaluate and approve suppliers and vendors.
• Assign complaints to laboratory staff for investigation and propose corrective actions.
• Ensure that competent and authorized persons perform operational work on equipment, performance, and calibration.
• Authorize activities based on evaluations, experience, training, and satisfactory knowledge of testing, equipment, and calibration.
• Prepare job descriptions for each laboratory member.
• Ensure that all facilities required to perform tests in standard manners are available, such as energy resources, weighing, and environmental conditions.
• Review all environmental monitoring records on a monthly basis.
• Ensure that appropriate SOPs are available for all tests performed under the scope of accreditation.
• Ensure that open-hand instruments for all equipment are available in the laboratory, and personnel are trained to use them.
• Ensure that correct dates are transferred from raw data to final reports.
• Ensure that reference materials are certified against traceable certificates, and their standards are available, or internal standards used are validated before use.
• Analyze test reports, calibration dates, and other QC-related documents with log books, registers, formats, and sheets, and execute amendments only after approval from the quality assurance manager.
• All SOPs and methods must be prepared and approved.
• Enforce GMP compliance in production, QC, and warehouses.
• Be responsible for all documents, such as IQ, OQ, PQ, validation, and stabilities.
• Supervise the maintenance of monthly log registers for raw, finished, packaging, and stability records.
• Supervise inventory and consumption records of reagents and glassware.

Requirements:

• Knowledge of administrative and clerical procedures and systems.
• Knowledge of chemical composition, structure, and properties of substances.
• Mathematical skills, including arithmetic, algebra, geometry, calculus, statistics, and their applications.
• Knowledge of raw materials, production processes, quality control, costs, and techniques for maximizing effective manufacture and distribution of goods.
• Knowledge of human injuries, diseases, and deformities, including symptoms, treatment alternatives, drug properties and interactions, and preventive healthcare measures.

Skills:

• Critical thinking to identify strengths and weaknesses of alternative solutions.
• Monitoring and assessing self-performance, individuals, or organizations to make improvements or take corrective action.
• Determining how a system should work and how changes in conditions, operations, and the environment will affect outcomes.
• Identifying measures or indicators of system performance and actions needed to improve or correct performance relative to system goals.

Education/Experience:

• Bachelor's degree in relevant field.
• Minimum 5 years of experience in quality assurance and control.

Contact Information:

Submit your application with a cover letter and CV.