Glp-quality Assurance Personal

JOB DESCRIPTION Job Title GLP-Quality Assurance Personal Job Location Syngene International Limited Bengaluru About Syngene Syngene 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 s 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 s 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