Job scope: The QualityAssurance Manager is responsible for the overall direction, coordination and evaluation of all QA and Production/ factory staff. Developing and managing the plant quality control environments to prevent internal failures. Develop initiatives to improve plant performance against established quality measures resulting in reduced product holds and customer complaints. Ensure plant compliance with company and regulatory standards including compliance to PICS GMP standards; proactively manage and mentor QAand Production/ factory personnel. Act as the primary liaison regarding quality with Corporate Quality Assurance, customers and external regulatory agencies. Responsibilities: Demonstrate integrity, respect, teamwork, and equity in all aspects of the job including dealing with employees, customers; ensure that the plant has adequate controls, programs, and organizational structure in place to comply with all regulations, and customer requirements. Ensure that appropriate records are maintained and that a well -documented tracking and recall program exists and that all employees are trained onall aspects of the program. Design and implement adequate tests and procedures to provide statistically significant controls for the safe manufacture of products. Ensure that managers and staff participate in training activities to stay current with regulatory and industry requirements. Provide technical expertise to all departments around training, continuous process improvement, and product development. Write, maintain, and ensure compliance with new product specifications. Interface with all regulatory agencies and customers insuring optimum support. Serves as safety model; promote a high level of safety awareness and continuous improvement practices. Commit to ensuring that products produced meet all food safety and quality requirements. Establish, monitor and maintain all appropriate quality programs and procedures, testing methodologies and test equipment to assure compliance to specifications and to federal, state, and local regulation for all products. Coordinate resolution of all quality management issues. This includes reporting on KPI&aposs, corrective action plans, analytical/microbiological issues, held inventory disposition. Manage and direct the staff responsible for microbiological and other quality control testing. Responsible for evaluation and resolution of customer/consumer product quality issues. Ensure all quality related information required for regulatory reviews and reporting is maintained by the plant. Ensures effective safety procedures, tools and record keeping are managed through site leadership. Adheres to company GMP&aposs (good manufacturing practices), safety procedures and all other quality processes. Serve as QA lead on analytical projects teams and product operational teams. Collaborate with regulatory to support IND filling/amendments in all the necessary documents. Evaluate resource requirements to support projects and assure projects remain within budget. Assisting to inspect/manually test the products before, during and after manufacturing process. Collect, analyze and interpret statistical quality data and record keeping Timely up-dating of SOPs ensuring strict compliance of the same To report the quality of the work to Chief Executive Officer . Implement the Quality Standards and assure ongoing compliance with quality and industry regulatory requirements Do the product registration with local and international authority. Investigate customer complaints. Perform other duties as may be required or necessary. Authority to release batch number. You are also required to carry out such other duties and job function in which you may be instructed from time to time by the Chief Executive Officer. QUALIFICATION AND EXPERIENCES Bachelor degree in Science or equivalent Self-motivated and able to work independently. Minimum of 5 years of experience within a regulated pharmaceutical environment Mature in personality and positive working attitude. Computer literate. Show more Show less