Position- Officer API Production

 

Qualification – B.Sc./ M.Sc.

 

Exp-  3 to 8 Years of experience

 

Job Description- Officer Production Penam

 

Candidate from API regulatory plant will be preferred

 

Job Responsibilities :-

 

Carrying out the batch operations with safety, cGMP and SOP. BPR filling & on-line documentation and maintain the adequacy & accuracy with respect to data integrity. Maintain SOP compliance records with accuracy. Charging of batches & batch processing as per BPR & SOP. Handling and operation of the equipments as per SOP. Cleaning and sterilization of equipments and integrity testing of sterile grade filters. Planning the work of technician and follow up. To maintain housekeeping of owned area such that efficacy, purity and safety of product is ensured & ensure the cleanliness of equipment and its surroundings. Effective communication to superiors as well as subordinates in order to carry out work and its follow up according to instructions. Ensure good housekeeping in surrounding working area and personal hygiene. Sterilized articles unloading from sterilizer and transferring to respective place and aseptic connection. Execution of process simulation, validation / revalidation, qualification, requalification of equipments and system as per protocol. Coordination with IPQA, QC and Micro for PCO, Campaign changeover cleaning and In process sampling. Environmental monitoring of controlled and critical area. Review of Calibration reports, FMS trends and alarms. Calibration of sensors (Steam sterilizer, DHS and Kaye Validator). Checking of Raw material and Packing material, labeling and packing of FP. Verification of all critical routine operations. To perform & verify the cleaning & sanitization of articles, equipments & area as per respective SOP. To Complete all assigned training on time. To Maintain shop floor discipline and ensure harmonious relationship among employees Execution of Protocol based activities To be 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 leaving the workplace. To do the entries of records as per their respective SOP’s (equipment log book, cleaning records etc.) To Check the entries recorded by doer as per respective SOP’s (equipment log book, cleaning records etc.)