Senior Research Associate - Process Scale-up Job in Stelis Biopharma

Group Company: Stelis Biopharma Private Limited

Designation: Senior Research Associate (A75)

Office Location: Jigani Bangalore

Years of experience: 3 to 6

Salary Range: INR to

Position description:

Description: .

Shall work with CMO to monitor & ensure adherence to the execution of the processes planned for scale up/ tech transfer activities.

Primary Responsibilities:

• To ensure compliance in all areas ofmanufacturing and ensure all time readiness for customer and regulatory audits.
  
• Maintain data integrity in all activities at site and ensureappropriate and adequate traceability
• Involved in day to day activitiesrelated to fill finish and formulation operations of injectables
• Buffer preparation&formulations and operation of various equipment's in Fill finish area.
• Commissioning & qualification of newequipment's in Fill finish Process scale up lab.
• Record eachActivity performed in log note book, and other documents such as BMR, BPRdocuments.
• Handlevarious instruments like Isolator operations, colonar filling machine, mixingvessel, pressure vessel, dosing pump, LAF, Sticker labelling machine and visualinspection activity etc.
• Understand the operating principle of each instrument andunit operations being handled and provide necessary support duringtroubleshooting activities
• Preparation of documents like SOPs study protocols &ability to work in a dynamic environment
• Completion of QMS elements like Deviation,change control, investigation, CAPA, OOS, OOT, QMR etc. as applicable
• Qualification & validation activities & activelyparticipate in process validation, cleaning validation.
• Participate & conduct on the job & cGMPtraining related to process scale up lab of Stelis Biopharma Unit 1
• Any other activities assigned by the reporting manager shallbe performed after training over the respective activities.
• Working with all members of staff to maintain & developthe positive progression culture within the organisation.
• To provide functional support/ impart training to the relevant personnelon the standard operating procedures and cGMP trainings
• Communicate with other departments, Customers, suppliers& other service provides.