.Job Responsibilities: Supervise and coordinate activities of associates engaged in inspection and document control-related activities to ensure adherence to company quality standards and customer specifications.Establish and report on the performance of the Quality Management System, including trends that help decision-making for targeted actions.Ensure that procedures and specifications are appropriate and followed. Review any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specifications- including changes to these documents.Monitor the production processes and ensure that appropriate in-process controls are performed during manufacturing operations and results are satisfactory. Involvement in decision-making to stop production if quality standards are not being met.Document and investigate deviations, and non-conformances. Facilitate, assess, evaluate, and recommend for approval site investigations and CAPA records.Review and recommend for approval/rejection of reprocessing and rework procedures. Oversee the verification of status stickers issued to operations. Oversee the inspection and AQL sampling of finished products.Review compliance of completed Manufacturing records (batch records, forms, etc.) and quality control records (test/analytical results). Ensure timely closure of records.Oversee sampling of incoming raw/packaging materials for laboratory testing.Oversee physical testing of packaging material components using validated methods against scientifically-derived, fit-purpose specifications.Act as the Internal Quality Lead Auditor. Create an audit program and schedule auditing assignments.Review complaints to determine if they relate to a failure to meet specifications and investigate and report to FDA if it is serious and unexpected.Assist in Annual Product Review/Annual Report Compliance.Alternate to sign the final release of the finished product in the absence of the Technical Services Manager.Maintain confidentiality of information.Job Qualification:BSc degree in a scientific or technical field preferably in Life sciences, Chemistry, Pharmacy, or engineering required.At least three (3) years experience in Quality Assurance in a pharmaceutical firm, with a minimum of one (1) year in a Supervisory position.Strong working knowledge of cGMP principles.Strong working knowledge of technical and quality concepts of the manufacturing and testing of pharmaceutical products.Experience in participating in deviation investigations, determining root cause, and developing corrective action plans.Team player with strong interpersonal, organizational, and communication skills.Good moral character
