Experience Required: Diploma in engineering/ m with 4-6 years of experience in core packing area & Exposure to CVC packing machine candidate shall be preferred. Should have expertise in packing operation & also Should have exposure in machine installation & qualification activity. Should have exposure to regulatory audits such as MHRA, USFDA etc.
Followings will be the responsibilities of the position holder:
1. Responsible for Operation, cleaning and primary maintenance of Uhlmann packing machine.
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 packing, to prepare new recipes set process parameters in PLC/SCADA as per BMR & ensure its correctness before start of packing operation.
4. Issuance, utilization, cleaning, and retrieval of packing change parts with its inventory.
5. Responsible for set up, changeover, and operation of various packing equipment’s but not limited to packing 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 poli