High Salary Compliance Qa Auditor

Job Title Assistant Manager -Compliance QA Auditor Job Location Bangalore 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 To coordinate process excellence projects in Translational Clinical Research to ensure quality compliance with GCP systems practices Complete strategic projects and Kaizen events for GCP Quality domain in alignment with Syngene s strategic deployment plan 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 ensure that GCP QA Audit Management Corrective and Preventive Action CAPA Management Systems are in compliance To conduct audits for the vendors accompanying with other QA auditors during audit of vendors To conduct system audits for - Human Pharmacology Unit Clinical To handle external clients Standard Operating Procedures SOPs Preparation and revision of SOPs relevant to their area review of SOPs from relevant departments Any other responsibilities as indicated in relevant SOPs Change Control Take relevant change controls review of change control taken by the departments follow up of the same for closure Record control - ensure that all records are written legible Control and maintain records in the QA department Review relevant documents qualification and validation documents pertaining to the Computerized system Audit relevant computerized system during study audits and system audits Analyze the root-cause for non-compliance deviations analyze trends observed if any and advice on resolving issues Any other job indicated by the Management and or Manager or Head QA Role Accountabilities Accountable for the above-assigned role Leadership Capabilities Must have basic communication skills to interact with dept training coordinator Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 8-10 Years Demonstrated Capability as per the above role Education M Pharm or Master s in Science Skills and Capabilities Microsoft Office Basic computer skills MS Office self-motivated able to communicate in English 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