Assistant Manager - QC

Job Description

Job Summary : Experienced QC professional with 8-10 years in pharmaceutical quality control and compliance. Responsible for preparing specifications, test methods, and maintaining GMP, GDP, and GLP standards. Supports regulatory affairs, handles deviations, OOS, and change controls, and reviews analytical reports. Proficient in SOP creation, method updates, and team training as per cGxP and regulatory guidelines. Responsibilities: Preparation and updating specifications and test methods to ensure compliance with statutory and company standards Preparation of specification for input materials, intermediates, active pharmaceutical ingredients, finished products and stability products to ensure compliance with company standards. Maintenance of GMP, GDP & GLP in work To maintain Quality Control documents as per statutory requirements Updation and analysis of methods and analysis as per current cGCPL guidelines and regulatory requirements. Support to Regulatory affairs departments, as required Adherence to cGMP, ISO 14001, FSSC 2200 and HACCP norms and guidelines as required Preparation of SOP and related documents Initiating and involving in the incident, deviation and OOS. Initiating change control and edit form to make any changes required in the specifications, standard testing procedures, raw data sheets and SOP and closing the same Review and approval of analytical reports as required Training of concern persons related to quality documents as required Education Qualification: MSc Chemistry Years of Experience : 8 to 10 Years