Sr. Officer

Job Description

Position- Officer API Production

Qualification - B. Sc. / M. Sc.

Exp- 4 to 8 Years of experience

Job Description- Officer Production Penam

Candidate from API regulatory plant will be preferred

Job Responsibilities :-

1. To carry out planned production activities in shift as per production schedule and to coordinate with concerned departments and check the operations are being performed as per the BPR. Report if any deviation in the process & investigate it.
2. To complete production documents (BPR, Equipment Logbooks, Cleaning Records, Calibration records , Area monitoring records , Bounded Books , Raw material & Packing material records, Finish good records etc. ) and to Check the entries recorded by doer for their respective SOP.
3. Issue/Review plant documents. To review the draft MPR w. r. t. raw material qty. & ratio, Equipment number, Process parameters, Limit of in-process checks etc. during preparation.
4. Issuance of Packaging Material from Warehouse as per production planning, storage as per procedure. Dispense Raw Material and packing material as per SOP and perform related documentation including SAP activity.
5. To assist Manager-Production in handling internal/external audits and its compliance.
6. To perform In-process analysis & maintain related documentation.
7. Maintain the facility and associated documentation during manufacturing in accordance to cGMP/Regulatory requirements by following SOP s and established procedure.
8. Maintain plant as per requirement of ISO-14001 & OHSAS-18001 and updated related documents. To ensure the implementation of EHS and safety practices during the execution of work
9. To ensure the training assigned by the department / organization are attended / completed as per prescribed timeline and related documents are up-dated.
10. To available on their dedicated workstation & proper hand over the charge to another employee (who is well trained to perform the task) and inform his superior prior to leaving the workplace.
11. To follow the cGMP practices during work & ensure the implementation of cGMP and SOP compliance during work & implement the recommendations of internal / external auditors.
12. To maintain & ensure the cleanliness of equipment and its surroundings.
13. To execute Validation activities and also engage in maintenance of plant & machinery as per procedure & maintain the related records.
14. Optimum utilization of available resources for maximum productivity.