Zuventus Injectable Production Officer

Washing Area

1. To carry out the sterilization related activities in Bung Processor, H.P.H.V steam sterilizer.

2. To carry out the operation and cleaning of vial washing machine & Depyrogenating tunnel as per SOP.

3. To ensure that preventive maintenance of the machine which done by maintenance department as per schedule.

4. To assure the proper maintenance of change parts of Bung Processor, H.P.H.V steam sterilizer, Depyrogenating tunnel & vial washing machine

5. To carry out the all filter integrity & maintain related documents.

6. To maintain BMR & Equipment logbooks and general logbooks.

Manufacturing (Aseptic Area)

1. To carry out the sterile Area related activities in Filling & Sealing.

2. To assure the proper maintenance of change parts of Filling Machine & Sealing Machine.

3. To perform the Sterile area Blending Activities & proper manage the related documents.

4. To maintain BMR & Equipment logbooks.

5. To maintain safe and clean work environment by following current good manufacturing practices (cGMP), standard operating procedures & monitoring environment.

6. To Adhere Production SOP while performing Production activity.

7. Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.

8. To co-ordinate with Engineering department for preventive and break down maintenance, modifications etc.

9. To maintain good housekeeping.

Documentation QMS

1. To follow the production plan and work accordingly.

2. To check BMR against SAP BOM and verify the quantity dispensed as per BMR.

3. To train personnel in the concerned area as per SOP.

4. To coordinate and take follow-up from QA & QC Dept. regarding Line Clearance, in process checks, sample collection and its release for further process.

5. To coordinate with RM Store regarding dispensing of planned batches after communication with interlinked departments like packing, QA & PM store.

6. To ensure online SAP entries.

7. Completion of BMR and all related documents & in process checks as per product status & requirement as defined in BMR in shift, effective manpower handling by proper allocation & maintaining the quality norms as per company policy.

08. To prepare and maintain equipment qualification documents such as URS, DQ, IQ, OQ, PQ and assist QA/R & D/Regulatory Department etc. in finalization of Validation protocol and report by review of summary of Product Validation data for incorporation of critical product process parameters.

09. To review & revise BMR, BPR, MFR, SOP and formats as and when required.

10. To prepare and revise standard operating procedure, equipment master list, and equipment qualification plan as and when required.

11. To investigate the root cause of deviation in coordination with Quality Assurance after evaluation and deciding CAPA based on risk assessment and initiate any change by originating change control request after approval from all interlinked departments.

12. Identifying need and procurement of new equipment's, accessories and spares keeping productivity, quality and safety in mind.