3 Glp Principles Jobs

Date: 2 Aug 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Job Description Job Title: GLP-Quality Assurance Personal Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit. Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company&aposs integrity & quality standards Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene' s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose Of The Role This is an exciting opportunity to play a role in the GLP Quality Assurance Unit at Syngene. The role offers valuable exposure to aligning laboratory practices with GLP guidelines, which is crucial for ensuring the integrity and reliability of non-clinical safety and clinical studies. Additionally, it provides a chance to work in a regulatory environment, ensuring that Syngene adheres to national and international standards set by organizations such as OECD, FDA, ICH, and ISO. Role Accountabilities To Ensure compliance to Organization for Economic Co-Operation and Development (OECD) principles of Good Laboratory Practices (GLP), and ICH, WHO-GCLP. Handling of inspections and audits. Handling of QMS-Change controls, deviations, and CAPA Review of SOPs and study plans. Performing/scheduling study, facility, and process-based inspections for analytical and bioanalytical domains. Perform audit of study raw data & study report. Preparation and /or review of SOPs and other documents related to QAU. Review of general documents/SOPs, Study Plans, and Study Reports. Review of computerized system documents concerning OECD 17,21 CFR Part 11. Syngene Values All employees will consistently demonstrate alignment with our core values. Excellence Integrity Professionalism Specific Requirements For This Role Experience Demonstrated Capability Education Experience: 06-09 Years Knowledge of GLP principles as per OECD, and familiarity with ICH, FDA, and EPA guidelines in a GLP environment. Handling of QMS activities, including change controls, deviations, and CAPA. Proficient in reviewing SOPs and study plans for regulatory compliance. Good Understanding of data integrity policies and standards. Skilled in conducting inspections of studies, facilities, and processes in analytical and bioanalytical domains. Ability to audit raw and electronic study data and reports for accuracy and compliance. Experienced in preparing and reviewing QAU documentation and SOPs. Competent in reviewing equipment and computerized system qualifications per OECD Principles 17 and 21 CFR Part 11. Prepare the data for quality meetings. Skills And Capabilities Expertise in handling multiple software applications and tools Capable of thinking scientifically to address complex problems and develop solutions Work as a team and have a collaborative mindset Good communication skills Education Master&aposs degree in Pharmacology, or any Chemistry, with a strong foundation and comprehensive expertise Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status about public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities. Show more Show less

The role involves serving as the single point of scientific, administrative, and regulatory control for the study. You will actively participate and supervise all study activities, including animal dosing, clinical signs observation, data collection, and analysis, ensuring compliance with relevant regulations, OECD Principles of GLP, and SOPs. Additionally, you will be responsible for the operation, maintenance, and proper utilization of various equipment/instruments like centrifuges, laminar air flow systems, anesthetic machines, and syringe pumps. Your duties will also include the preparation and updating of SOPs relevant to in vivo and in vitro experiments. Moreover, you will be expected to effectively communicate important information to key study personnel, the sponsor, and other relevant scientists. You will have the authority to approve amendments and deviations to the study plan and must respond to QA findings promptly, ensuring their resolution in a timely manner. As part of this role, you will be responsible for approving study plans, amendments, and reports, as well as ensuring the timely archiving of the study in accordance with existing practices. You will also have all the responsibilities of a Study Director as outlined in the applicable SOPs.,

Job Title: GLP-Quality Assurance Personnel Location: Bangalore, KA, IN, 560099 Syngene International Limited, Bengaluru is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is a top priority, with a focus on ensuring safety guidelines, procedures, and SOPs are followed diligently. As a GLP-Quality Assurance Personnel at Syngene, you will play a crucial role in aligning laboratory practices with Good Laboratory Practice (GLP) guidelines to maintain the integrity and reliability of non-clinical safety and clinical studies. You will also work in a regulatory environment to ensure compliance with national and international standards set by organizations such as OECD, FDA, ICH, and ISO. Key Responsibilities: - Ensure compliance with OECD principles of GLP, ICH, and WHO-GCLP - Handle inspections and audits - Manage QMS activities including change controls, deviations, and CAPA - Review SOPs, study plans, and documentation related to QAU - Conduct inspections of studies, facilities, and processes in analytical and bioanalytical domains - Audit raw and electronic study data and reports - Review equipment and computerized system qualifications as per OECD Principles 17 and 21 CFR Part 11 Requirements: - Experience: 6-9 years - Knowledge of GLP principles as per OECD, ICH, FDA, and EPA guidelines - Proficiency in handling QMS activities - Ability to review SOPs and study plans for regulatory compliance - Understanding of data integrity policies and standards - Skilled in conducting inspections and audits - Competent in preparing and reviewing QAU documentation and SOPs Skills and Qualifications: - Master's degree in Pharmacology, Chemistry, or related field - Proficiency in handling multiple software applications and tools - Strong problem-solving skills with a scientific mindset - Ability to work collaboratively in a team environment - Excellent communication skills Syngene Values: - Excellence - Integrity - Professionalism Syngene is an equal opportunity employer dedicated to providing a safe and inclusive work environment for all employees.,