GLP-Quality Assurance Personal

As a GLP-Quality Assurance Personnel at Syngene International Limited, Bengaluru, you will have the exciting opportunity to contribute to the GLP Quality Assurance Unit. Your role will involve ensuring compliance with Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), as well as ICH and WHO-GCLP guidelines. You will be responsible for handling inspections and audits, managing QMS activities such as change controls, deviations, and CAPA, and reviewing SOPs and study plans. Your core purpose in this role is to align laboratory practices with GLP guidelines, ensuring the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory environment to uphold national and international standards set by organizations like OECD, FDA, ICH, and ISO. In addition to maintaining compliance with safety guidelines and procedures, your responsibilities will include contributing to the development of procedures that ensure safe operations and compliance with company standards. You will drive a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline in the workplace. It is essential to ensure the safety of yourself, your team, and the lab/plant by adhering to safety protocols and EHS requirements at all times. As a GLP-Quality Assurance Personnel, you are expected to hold yourself and your team accountable for achieving safety goals and complying with Syngene's quality standards. You will review safety metrics periodically and ensure that all mandatory trainings related to data integrity, health, and safety measures are completed on time by all team members. To excel in this role, you should have 6-9 years of experience and a Master's degree in Pharmacology or any Chemistry field. You must have knowledge of GLP principles as per OECD, along with familiarity with ICH, FDA, and EPA guidelines in a GLP environment. Proficiency in handling QMS activities, reviewing SOPs, conducting inspections, and preparing QAU documentation is essential. Additionally, expertise in handling multiple software applications, scientific problem-solving, teamwork, and effective communication skills are required for success in this role. At Syngene, we value excellence, integrity, and professionalism, and we are committed to providing equal opportunities for all employees.,