About Syngene : Syngene () is an innovationled 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: Team member – In process quality assurance
Role Accountabilities
Handling shift activities of IPQA.
Proving line clearance for batch manufacturing activities.
Review of batch manufacturing records.
Cell bank management
Perform audit trail review of cGxP computerized systems
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Specific Requirements For This Role
Experience: 48years
Skills And Capabilities
Experience in DS manufacturing activities (upstream & downstream process) of biological products (Preferably mAbs).
Should have knowledge on line clearance process of DS manufacturing activities.
Should have understanding on audit trails verification of GxP computerized systems.
Understanding on process equipment handling & operating systems.
Understanding on WH activities like material receipt dispensing and handling of rejected materials.
Basic understanding on cGMP regulations
Education: Master’s in life sciences / B.TechBiotechnology
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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