IPQA Team Member

Job Title: IPQA Team Member - Biologics

Job Location:Bangalore

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:

• Providing line clearance before starting of batch product change over.
• Providing line clearance for dispensing of raw materials.
• Verification of Raw materials and consumable for correct status labelling and storage conditions.
• Monitor critical parameters during manufacturing.
• Assessment of breakdowns of the equipments.
• Review and approval of Batch Manufacturing Records (BMR) SOPs Protocols Reports Risk assessments etc.
• Issuance and control of documents like Logbooks SOPs Annexures BMRs Protocols etc.
• Periodic review of EMS reports.
• Vial (Cell banks) issuance receipt and periodic reconciliation.
• Handling of QMS Deviations Incidents CAPA and Change Control.
• Monitor cleanroom parameters like temperature humidity and differential pressure.
• Ensure real-time documentation and compliance with GDP.
• Perform Audit trails for GXP computerized systems.
• Maintain Readiness of Regulatory and Internal quality audits.
• Participate in Process validation and Cleaning validations activities to verify the adherence of validation protocols and documentation.
• 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 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

Experience: 9-12years

1. Demonstrated Capability-

1. Knowledge on Biologics Manufacturing.
2. Knowledge on Regulatory guidance Audits and readiness
3. Good knowledge in MS Office tools.
4. Good understanding in QMS
5. Excellent communication skills (written and oral).
6. Co-Operation with team leads

1. Education -M. Sc. (Chemistry/Biochemistry/ and Capabilities:
   1. Good understanding in QMS.
   2. Handling a small Team.
   3. Basic knowledge in SAP. Having Track wise experience is a plus.
   4. Excellent communication skills written and oral.

   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.