Quality Assurance officer (API industry)

Quality Assurance officer (API industry) Company: Hikal Ltd Job Location: Bengaluru, Karnataka, India Employment Type: Full-time Experience Required: 2 - 5 years We are hiring for the Quality Assurance department from the API manufacturing industry experience only . Officer / Executive Experience in Quality Assurance API industry. Key skills: IPQA & AQA AQA Job roles : Review analytical data, test reports, calculations, and laboratory records. Ensure compliance with GMP, GLP, regulatory requirements, and approved procedures. Review and approve specifications, analytical methods, protocols, and standard operating procedures. Investigate deviations, out-of-specification (OOS), out-of-trend (OOT), and atypical results. Review method validation, verification, transfer, and stability-study documentation. Ensure data integrity and compliance with ALCOA+ principles. Perform audit-trail reviews of laboratory systems and instruments. Support CAPA, change controls, risk assessments, and laboratory investigations. Monitor calibration, qualification, and preventive maintenance of analytical instruments. IPQA Job roles : Perform line clearance before manufacturing and packaging activities. Monitor shop-floor operations for compliance with GMP, SOPs, and approved batch records. Verify dispensing, equipment status, material identity, and process parameters. Conduct in-process checks, sampling, and reconciliation. Review batch manufacturing and packaging records in real time. Ensure proper documentation and adherence to data-integrity requirements. Identify and report deviations, non-conformances, and process discrepancies. Support deviation investigations, CAPA, change controls, and risk assessments. Verify equipment cleaning, area cleanliness, environmental conditions, and status labels. Monitor hold times and adherence to validated processes. Coordinate the handling of rejected, returned, or quarantined materials. Participate in process validation, cleaning validation, and qualification activities. Support internal, customer, and regulatory audits. Coordinate with Production, Quality Control, Warehouse, Engineering, and other departments. Ensure batches are released for subsequent processing only after meeting defined requirements. MSc in Chemistry with 2 to 5 years, API Industry experience only. Note : Only male candidates to apply as it will be 24/7 Shift . operating environment. .