Officer

Job description

**Job Description** To maintain the discipline and decorum at the work place to create safe, healthy environment and working culture. To adhere with cGMP & SOP Compliance in the department and ensure safety & quality of product during manufacturing & packing operation. To receive & follow the instruction from the supervisors and complete the assign jobs precisely. To look after all the activity of assigned area. To achieve desired production targets (Shift/Month wise) and timely deliver the batches like commercial, exhibit, scale-up, etc. as per the commitment. To ensure the availability of sanitization solution and cleaning tools to perform area sanitization and cleaning and perform the area cleaning and sanitization of processing area and Drain. To perform the operation and cleaning of the equipment’s/ accessories. To work for the control of wastage and yield improvement during process operations. To do online in process checks and do necessary entries in BPR at regular intervals, update all process records, revision of BMR/BPR, SOP and other related documents. To maintain the discipline and decorum at the work place to create safe, healthy environment and working culture. To adhere with cGMP & SOP Compliance in the department and ensure safety & quality of product during manufacturing & packing operation. To receive & follow the instruction from the supervisors and complete the assign jobs precisely. To look after all the activity of assigned area. All time readiness for in-house and various regulatory audits. To prepare the status labels and maintain the area/ equipment’s/accessories with appropriate status labelling and keep the area readiness for line clearance. To record and maintain the log books i.e. equipment, accessories, weighing balance, cleaning and sanitization log book, Drain cleaning ,Environmental condition. To maintain the RM day store/PM day store / Quarantine Area/ Storage Area, Change part room with proper cleaning and appropriate status labelling. To perform the daily verification and monthly calibration of weighing balance and record the same in respective Log books. To perform the dispensed raw/ packing material verification during dispensing/material receipt. To perform weighing of materials and transfer of material from one area to another area as per requirement. To perform inspection of capsules/Bottle/empty Bottle/filled and sealed bottles/ carton inspection as applicable during operation. Issuance and retrieval of log books from QA. To check and ensure the accountability of the production accessories like Filter, Silicon Tubing, Sieves, Gaskets, Buffer solution, cartridge filter/ ink cartridge, lint free cloth, gloves. Regular updates on regulatory Guidelines and laws ex. - EU GMP, USFDA and Schedule M requirements etc. through continuous Trainings. To provide suggestion to increase productivity and quality. To prepare and maintain production documents like log books, calibration records as per its Schedule and preventive maintenance of the equipment, maintenance & calibration of equipment’s/instruments as per schedule To report any abnormalities as and when observed during any manufacturing/packing operation and avoid product mixing & maintain proper product & batch segregation. To ensure the final yield of the product after process completion as per BPR, perform destruction of waste & in process rejects generated during manufacturing & packing operation and perform scrap disposal as per SOP. To ensure timely completion of all the assigned trainings (offline/online) as per statutory as well as company requirement To educate team about cGMP compliances, machine operation, safety precautions during day to day work.