Ensure readiness of equipment and instruments for production processes.
Ensure availability of process raw materials, accessories and consumables before batch execution.
Prepare and review process, equipment and area-related SOPs and EOPs.
Prepare and execute process, area and equipment qualification and validation protocols.
Prepare reports related to process, equipment and area qualification and validation.
Prepare and review Batch Production Records (BPR).
Request and issue BPRs.
Prepare, review and execute study protocols.
Ensure readiness of downstream areas, corridors, washing areas and other supporting areas for manufacturing operations.
Ensure smooth functioning of shop-floor operations during manufacturing campaigns.
Raise and review change controls and deviations as required.
Handle SAP-related process and maintenance activities.
Operate downstream equipment for process and CIP/SIP activities.
Required Experience: 11–16 years
Qualification: M.Sc. / B.Tech; B.Tech in Biotechnology or Biochemistry
Relevant expertise: Biosimilar Manufacturing, Production Planning and QMS
Benefits will discussed during interview.