Title: QC Analyst
JOB DESCRIPTION
Job Title: Executive Quality Control Biologics
Job Location: Bangalore, Biocon Park
About Syngene : Syngene (www.syngeneintl.com) 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
Core Purpose of the Role:
- 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.
- Co-Ordinate with external vendors for ensuring timely calibration and PM activities.
- To ensure storage chambers are maintained at set t 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 co-ordination 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.
Role Accountabilities:
Seamless shift operations in coordination with team leader
Error free analysis
Timely completion of tasks
Leadership Capabilities
-This is an executive role and no leadership expectations
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
- Experience: 1-3 years
- Demonstrated Capability-
- Entry level Knowledge on Biologics Manufacturing and testing compliance requirements.
- Good communication
- Co-Operation with team leads.
Entry level in Biochemistry
- Education
B.Sc. or M. Sc. (Chemistry/Biochemistry)
4. Experience
1-3 years
Skills and Capabilities:
- Aggressive but assertive on task completion.
- Personal integrity and good attitude.
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.