Qa Auditor- Gcp Compliance

JOB DESCRIPTION Job Title Associate Manager Compliance QA Auditor Job Location Bangalore Job level 7-I 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 Role Accountabilities To coordinate process excellence projects in Translational Clinical Research to ensure quality compliance with GCP systems practices To lead the design and implementation of improvement initiatives or events for complex processes that have a large cross-functional impact to eliminate waste reduce cycle time and improve business performance as a part of continuous improvement To complete strategic projects and Kaizen events for GCP Quality domain in alignment with Syngene s strategic deployment plan To perform and assess GCP quality systems for Gaps and identify process excellence projects for implementation To perform data trending data analysis and present metrics To responsible for performing internal audits assess the systems and practices for improving the GCP Quality System practice independently and in consultation with GCP Quality Head To manage and perform Internal Audits for GCP Quality Systems To ensure that GCP QA Audit Management Corrective and Preventive Action CAPA Management Systems are in compliance To adherence to strategic direction set by GCP Head Quality when establishing near-term goals To conduct audits for the vendors accompanying with other QA auditors during audit of vendors To conduct system audits for - Human Pharmacology Unit To handle external clients To perform or assist any other relevant job with relevant training as and when required by Department Head or Management Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 10-15 years Demonstrated Capability Expert in Data Analysis Data Trending and familiar in PowerBI Knowledge in GCP GLP GMP with expertise in Data Metrics Green Belt in SixSigma Auditing skills Understanding of regulations Attention to detail Education M Pharm or Master s in Science 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 with regard to 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