Stelis BioPharma | Walk-In for Manufacturing (Down Stream) | 17th November 2018 | Bangalore

Job Description
1) Job Objectives:
This position will form an integral in the Drug-substance facility and will assist the installation and commissioning activities like FAT, SAT, IOQ and PQ of all downstream process related equipments and facility.
This position is responsible for the preparation of Documents like SOPs related to the Equipments and BMR related to process and cleaning
He or She will be responsible for all sort of validation activities pertained to process, equipments and facility.
He or she will be a part of all routine manufacturing operations of downstream and relevant cGMP requirements.
He or she will be responsible for validation, commercial and clinical campaigns.
2) Primary Responsibility
Performing the FAT & SAT at Vendor sites and at our facility respectively.
Performing the IQ, OQ, PQ related to Downstream processing Equipment in Drug substance facility.
Responsible for validation of equipment and facility.
Responsible for process and cleaning validation activities.
Prepare & review of all SOPs/Protocols related to Equipment facility.
Handling commercial and clinical manufacturing activities of Drug substance facility
Responsible for implementing Good Manufacturing practice in the drug substance suite
Responsible for Process related SAP activities
Preparing the facility ready for Regulatory and customer Audits.
Responsible for Deviation initiation and Implement CAPA wherever necessary.
Training of new Joiners.
Preparation of BMRs and other Validation Protocols.
Tracking and updation of day to day activities

Hands on experience of Chromatography, TFF, Viral filtration skids etc
Biopharmaceutical operations