Injectable Fill Finish

LI-JK1 Job Title Injectable Fill Finish Expert QMS and Mfg Department Formulation production Job Location Bengaluru India 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 Responsible for Quality Systems of Injectable formulation Production activities Role Accountabilities Responsible for support to plan for manufacturing and packing of Injectable manufacturing facility for small molecule formulations large molecules biologics products He should have expertise in aseptic filling and sealing areas is mandatory Responsible for ensuring compliance and management of QMS documentation like change control Deviation Investigations OOS OOT customer complaints validation protocols CAPA APQR Audit management etc both manually and in electronic Quality management system EQMS Coordination with cross-functional departments for completion of production targets and support for achieving of production numbers for weekly monthly and annually Responsible for facility planning to achieve monthly targets capacity utilization monitoring and upkeep for smooth functioning of production activities clinical batches and manufacturing commercial batches Responsible for approval of purchase orders for new instruments equipment accessories and consumables for day-to-day functioning of the formulation unit Coordination with other functions like project management HR Formulation and development regulatory QA and QC with respect to various plant-related activities for completion of production targets and support for achieving of production numbers of weekly monthly and annually Ensuring monthly production targets are met as required by complying with applicable predetermined quality standards Responsible for implementation of cGMP requirements to meet compliance w r t USFDA EU and MHRA standards Supported in the preparation of various client visits and regulatory and QP audits Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Experience 11-15 years of relevant experience Skills and Capabilities Team player Result oriented and focus Education Bachelor pharmacy master s degree in pharmacy 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 LI-JK1