Job Description
● Use a variety of measures and management systems, such as total quality management.
● Devise and establish a company's quality procedures, standards, and specifications.
● Review quality requirements and make sure they are met.
● Look at ways to reduce waste and increase efficiency.
● Define quality procedures in conjunction with operating staff.
● Make suggestions for changes and improvements and how to implement them.
● Select and assign staff, ensuring equal employment opportunity in hiring and promotion.
● Coordinate activities by scheduling work as assignments, setting priorities, and directing the work of subordinate employees.
● Ensure incidents, corrective actions, preventive actions, change controls, deviations, and OOS related to process testing, are investigated, in and timely close.
● Approve or reject drug substances/products manufactured, processed, and packed as per the compliance requirements.
● Prepare, review, and verify documents including standard operating procedures, technical protocols and reports, and other documents in support of regulatory submissions.
● Ensure deployment of GMP training to quality control personnel on Quality System
Procedures and systems.
● Ensure regulatory inspection readiness and ensures expertise and support are provided to internal and external regulatory inspections.
● Evaluate and verify employee performance through the review of completed work
assignments and work techniques.
● Identify staff development and training needs and ensures that training is obtained.
● Ensure proper relations and conditions of employment are maintained.
● Maintain records, prepared reports, and composing correspondence relative to the work.
● Review and verify all cases for validity and accuracy.
● Timely approval of incoming batches, batch inspection, and release according to SOPs.
● Maintain QC master files for all registered products.
● Maintain relations with cross-functional teams like QA, regulatory, and Production for technology transfers and method-specific validations.
● Face national and international audits, customer complaints, and compliance.
● Maintain a good laboratory team to achieve quality level throughout the batch manufacturing, testing, and releasing.
● Perform and supervise molecular tests such as Bioassay, ELISA, SDS-PAGE, HCD, and HCP.
● Approve or reject, as he sees fit, starting materials, packaging materials, intermediate, bulk, and finished products.
● Ensure that all necessary testing is carried out and the associated records evaluated.
● Approve specifications, sampling instructions, test methods, and other quality control procedures.
● Approve and monitor any contract analysts.
● Ensure the qualification and maintenance of his department, premises, and equipment.
● Ensure that the appropriate validations are done.
