Junior Officer Production
2 months ago
Experience Required : Diploma in engineering/ D.Pharma with 2-3 years of experience in core granulation area & Exposure to Isolator & GEA blender candidate shall be preferred. Should have expertise in negative isolators & in granulation department exposure in machine installation & qualification activity. Should have exposure to regulatory audits such as MHRA, USFDA etc. Person working in a containment facility are preferred.
Followings will be the responsibilities of the position holder:
1. Responsible for Operation, cleaning and primary maintenance of negative isolators, sifters & GEA dry granulation line equipments.
2. Competent for (entry) recording of activity in logbooks, Batch manufacturing record & Responsible for completing documentation as required in the manufacturing of product and the cleaning of facilities and equipment, following cGMP’s and good documentation practices.
3. To perform all in-process checks and monitoring of all intermediate processes in granulation to prepare new recipes set process parameters in PLC/SCADA in blender HMI & ensure its correctness before blender revolution.
4. Issuance, utilization, cleaning, and retrieval of sieves, valves & proper handling of machine change parts with its inventory.
5. Responsible for set up, changeover, and operation of various manufacturing equipment’s but not limited to granulation department.
6. Ability to read, write and communicate in English, Strong work ethic, professional approach, and ownership of lines production performance.
7. Ability to read & understand SOP’s, Batch Records, training documents & Basic computer knowledge.
8. Ensures accurate and timely completion of all equipment logs and documentation.
Understands and adheres to all cGMP and FDA regulations.
9. Responsible for reporting and/or escalating any conditions or problems that may affect the quality or integrity of product to supervisor and HOD production.
10. Responsible for maintaining a neat, clean and safe working environment at all times and notifies supervisor immediately of any safety concerns, accidents or injuries are observed.
11. Understands and adheres to all Company policies, procedures, SOPs and Safety regulations.
12. Willingness to do overtime as needed & responsible for performing additional task, related duties as assigned.
13. To ensure all in-process checks and monitoring of all intermediate processes, To check set process parameters in PLC/SCADA as per BMR before machine run in granulation area.
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