Ipqa Drug Specialist

5 days ago

Bangalore Karnataka, India Syngene International Full time

JOB DESCRIPTION Job Title IPQA Drug Specialist 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 Line Clearance process overview Product change over Timely area readiness Cleaning EMS OOS status and ensures availability of documents and material status Monitoring of process through process step verification Reviewal of Batch Manufacturing Record to check compliance from stepwise process execution till written instructions Equipment utility Qualifications Calibrations PM verification Utility Computer system validation Process validation and cleaning validation Target Monitoring for batch related process activities cGMP compliance and verification overview of BMP facility Utilities SOP preparation and review Training GEMBA principles Quality management system investigation Role Accountabilities Anytime audit readiness Timely area readiness Cleaning EMS OOS status and ensures availability of documents and material status for manufacturing Utility Manufacturing area and document compliance Equipment utility Qualifications Calibrations PM verification Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 6-9 years Demonstrated Capability - Process QA Manufacturing compliance Education MSc 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

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