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
Core Purpose Of The Role
Plate based and Bioassay analysis
Operating in shift and ensuring release of Inprcoess/Finished product samples/Stability samples within TAT and by adhering to compliance norms.
Ensuring the calibration of instruments and handling breakdown in coordination with vendor.
Adhering to good laboratory and analytical procedures.
Role Accountabilities
To handle the Plate based and cellbased Bioassay analytical techniques
To handle the Inprocess and Finished products analysis in shifts
To perform the analysis of Stability samples.
To handle the calibration of QC instruments/Equipment.
To ensure the completion of trainings allotted in time and support the team lead for achieving the deliverables.
Adhere to the SOP/IOP and perform the analytical activities.
Adhere to the good laboratory practice and compliance.
Ensure error free analysis and documentation.
CoOrdinate with external vendors for ensuring timely calibration and PM activities.
To ensure storage chambers are maintained at set temperature limits and take timely action in case of any excursions.
To ensure the instrument/equipment are in calibrated state.
Ensure the breakdowns if any are rectified in time and instrument is made up and running within shortest possible time in coordination with service provider.
Ensuring all time audit readiness and preparation prior to audits.
Ensuring completion status of action items of CAPAs triggered through observations of previous audits.
To support any other activity allotted by the team lead.
Leadership Capabilities
Continuous Learning and Improvement
Accountability and Integrity
Collaboration with in the team
Aggressive but assertive on task completion.
Personal integrity and good attitude.
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Experience
Specific requirements for this role
36 years of experience in Biopharma manufacturing/testing/compliance/Quality control.
Skills And Capabilities
Entry level Knowledge on Biologics Manufacturing and testing compliance requirements.
Good communication
CoOperation with team leads.
Education
Bachelor/Master of Science / Master of Technology Biotechnology/Bioprocess Engineering
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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