Title: Officer
Date:
Jun 10, 2025
Location:
Dewas API - Production Block 5
Company:
Sun Pharmaceutical Industries Ltd
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.)