Senior QC Analyst Biologics

JOB DESCRIPTION

Job Title: Senior QC Analyst - Biologics

Job Location: Bangalore Biocon Park

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 companys 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 integrityhealth 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 perform Analysis of Raw materials
• To support inspection and testing of Raw materials
• To handle the Inprocess and Finished products analysis in shifts
• Shall be able to work in A B and C shifts on rotational basis
• To perform the analysis of Stability samples.
• To handle the calibration of QC instruments/Equipment.
• To support method transfer/method validation activities
• To ensure the completion of training 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 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

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this role

1. Experience: 3-6 years
2. Demonstrated Capability-

1. Knowledge on Biologics Manufacturing and testing compliance requirements.
2. Good communication
3. Co-Operation with team leads
4. Shift support
5. Commitment

1. Education - M. Sc. (Chemistry/Biochemistry)

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 addition Syngene will provide reasonable accommodations for qualified individuals with disabilities.