Opening For Officer/ Sr. Officer- [email protected] Otsuka Pharma, Ahmedabad
Experience: 2-7 yrs
Qualification: B.Sc / B.Pharm / M.Sc / M.Pharm
- To ensure the cleanliness and environmental norms of various area like dispensing, compounding, filling, capping, including airlocks and if any deviation is found, get it corrected immediately and then start the further process.
- To ensure cleaning and disinfection of floor, ceiling, wall and equipments.
- To ensure that the maintenance of dispensing compounding, filling, capping, including airlocks is as per Standard Operating Procedure (SOP) norms.
- To ensure that the cleaning is done as per SOP and then start further activity, in case of material spillages.
- To ensure that only one material is dispensed at a time, to avoid any mix-ups.
- To check the material identity and quantity against Batch Manufacturing Record (BMR), before starting of mixing activity.
- To ensure the availability of clean room garments.
- To supervise the behavior of workers / Technicians / Assistants in clean room.
- To check the online rejection and take immediate corrective action to minimize it.
- To ensure not to start the sterilizer process if found any abnormality in sterilizer.
- To ensure not to start next cycle without rectification of problem, in case of any abnormality observed like in printer, in recorder, in temperature, pressure, and utility supply during the sterilization of any product.
- To check the equipment after preventive maintenance and if found any dissatisfaction, ensure not to start further process.
- To carry out planning of material issue and dispensing as per priority of batch manufacturing.
- To prepare documents regarding material issue and dispensing.
- To issue the material from store as per Batch Manufacturing Record.
- To check the availability of washed and depyrogenated scoops for material dispensing.
- To ensure the availability of fresh Water for Injection (WFI) for hand wash and Iso Propyle Alcohol (IPA) for disinfections.
- To ensure the hand dryer is in working condition.
- To dispense the materials as per BMR, verify it and supply to compounding room, from time to time.
- To follow SOP and also guide the workers for the same.
- To give training to personnel.
- To ensure the batch manufacturing process is done as per Batch Manufacturing record.
- To control the timing of Cleaning In Process (CIP) / Sterile In Process (SIP) and batch manufacturing process, to start the production timely.
- To do the Bubble Point Test (BPT) / Forward Flow Test (FFT) of product filter before and after filtration and Water Intrusion Test (WIT) of air filters.
- To maintain the records online.
- To ensure that the material has status label and lying at its proper place.
- To remove the scrap from time to time with established procedure.
- To carry out preparation and filtration of disinfectant and IPA.
- To ensure that the selected recipe is correct for particular product.
We are looking for qualified and experienced candidates for our Quality operations. Candidates possessing good communication skill and exposure in Parental formulations
Urgent Opening for Packing Executive @ Otsuka Pharma, Ahmedabad
Experience: 6-10 yrs
Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm / Diploma
- To ensure the issued material is as per requirement and the material quality is as per specification.
- To ensure that the Officers / Workers are working as per standard operating procedure.
- To supervise the packing online at frequent intervals as defined in the Standard Operating Procedure (SOP).
- To crosschecks the available packing material with proper labels and status.
- To ensure the label, carton does not mix-up, in any case.
- To frequently ask the questions regarding productivity and quality to the workers and find out the training needs.
- To recheck, if any abnormality observed in reconciliation of any material and rectify the problem.
- To plan for retraining for staff / workers, if training evaluation is found dis-satisfactory.
- To ensure the line clearance of packing before starting the packing of new batch, in coordination with Officer In-Process Quality Assurance (IPQA).
- To ensure the issue of material of the batch and taking the clearance from the Officer IPQA, prior to schedule of respective product packing.
- To provide the data to transfer the packed goods to the finished goods store in coordination with Sub-department Manager of Production.
- To ensure the timely packing of unpacked goods from the General Quarantine area.
- To ensure the availability of packing material with proper labels and status.
- To ensure the reconciliation after completion of batch.
- To ensure the samples of each packing batch is collected as per Quality Assurance (QA) and Quality Control (QC) requirement.
- To ensure to destroy the rejection generated during packing, in presence of Officer IPQA.
- To ensure the status tags are displayed properly so that the status of each material issued and packed is maintained as per the regulatory requirement and Standard Operating Procedure.
- To ensure the Good Manufacturing Practice (GMP) norms are followed and maintained all throughout the packing.
- To train the work force for critical operations like visual inspection and labeling.
- In the absence of Officer, Executive will ensure his roles and responsibilities.
- In the absence of Executive, Sub-department Manager will ensure these roles and responsibilities.
If interested, then kindly share your resume on [email protected]or contact us on 91-2717-667000