Junior Officer

Long Description

Department: Production
Designation: Jr. Officer - Production (E0)
Working Section: Compounding Area

    Comply with all cGMP, GxP and any other applicable regulatory requirement, including EH&S requirements.
    Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task.
    Conduct all tasks/activities as per the applicable SOPs. Report any difficulty or deviation in following the procedure/instruction to immediate supervisor/managers. 
    Report any quality concern or suggestion for improvement to supervisors/ managers.
    Manufacturing / processing of batches of assigned products under supervision as per instructions given in the BMR.
    Responsible for handling of manufacturing and autoclave activities 
    Responsible for Operation of various machine link compounding vessels, CIP and SIP system, stem sterilizer, filter integrity test, PH and D.O meter, weighing balance calibration and verification etc.
    Up-keeping area and machines as per GMP requirements.
    To Support Quality Management Systems and to report any discrepancy, abnormity, non-conformance or any incidence observed to the Department Head and QA Head.
    Receipt of RM and PM from Warehouse and ensuring overall cleanliness of areas.
    Doing operations as per the SOPs and BMR with online recording in respective documents as applicable.
    To ensure self-hygiene before entering in the production area and follow all the other rules & regulation set by HR department.
    Performing in-process checks as per respective BMR and recording of results of in respective documents as applicable.
    To fulfil the training need as per current needs with respect to cGMP, Job, safety, health & Hygiene by attending the training programmes.
    Cost effectiveness in production operation by controlling overtime, revenue expenses and achieving standard yield.
    Critically monitoring of the environmental conditions with a view to meet the standards mentioned in BMR and SOP.
    Ensure calibration and preventive maintenance of manufacturing equipment and instruments as per approved schedule and the results of same meeting the standards.
    To perform line clearance activity during batch to batch and product to product change over and ensure the compliance as per SOP.
    To ensure the audit compliance.
    Trouble-shooting: To attend the problems of machine and process as and when necessary.
    Any other assignment allocated by production Head.
    To attend required cGMP/ On Job /Functional training activities as per planner.

Competencies

Education

Work Experience

5-7 Yrs.in injectable Manufacuring.