Job
Description
? Job Description: ? ? We are looking for a skilled and proactive QA/QC professional with 2 5 years of experience to join our quality team. The candidate will be responsible for executing and overseeing quality assurance and quality control activities in compliance with regulatory and company standards. ? ? Key Responsibilities: ? ? Quality Control? ? Perform analytical testing of raw materials, in-process samples, and finished products. ? ? Operate, calibrate, and troubleshoot instruments such as HPLC, UV-Vis, GC, FTIR, and KF. ? ? Prepare and review analytical documentation including test reports, COAs, and calibration records. ? ? Guide and Mentor QC Executives / Trainees for analytical testing ? Quality Assurance? ? Review batch manufacturing and packaging records (BMR/BPR). ? ? Investigate and document deviations, OOS, OOT, and implement CAPA with timely closure. ? ? Review and manage controlled documents (SOPs, protocols, forms) issuance, retrieval, and archival. ? ? Perform internal audits; support regulatory audits (e. g. , WHO, ISO, etc. ). ? ? Oversee GMP, GLP, hygiene training for production and QA/QC staff. ? ? Coordinate stability studies, analyze trends, and maintain stability protocols and logs. ? ? Ensure data integrity in documentation and electronic systems. ? ? Participate in risk assessment and mitigation for quality events. ? ? Support technology transfer, scale-up, and cross-functional quality activities. ? ? Evaluate and audit vendors and suppliers as part of QA oversight. ? ? Requirements: ? ? 2 5 years of hands-on experience in analytical techniques and instruments in a regulated environment. ? ? Strong understanding of cGMP, GLP, and ICH regulatory requirements. ? ? Proficient in analytical instrumentation and documentation practices. ? ? Ability to handle audits, deviations, and quality systems independently. ? ? Excellent communication, collaboration and organizational skills. ? ? Team player with attention to detail and accuracy. ?
