Job Description

JOB DESCRIPTION:

Experience Required : Diploma in engineering/ D.Pharm with 4-5 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:

• Responsible for Operation, cleaning and primary maintenance of negative isolators, sifters & GEA dry granulation line equipments.
• 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\xe2\x80\x99s and good documentation practices.
• 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.
• Issuance, utilization, cleaning, and retrieval of sieves, valves & proper handling of machine change parts with its inventory. Responsible for set up, changeover, and operation of various manufacturing equipment\xe2\x80\x99s but not limited to granulation department.
• Ability to read, write and communicate in English, Strong work ethic, professional approach, and ownership of lines production performance.
• Ability to read & understand SOP\xe2\x80\x99s, Batch Records, training documents & Basic computer knowledge.
• Ensures accurate and timely completion of all equipment logs and documentation. Understands and adheres to all cGMP and FDA regulations.
• Responsible for reporting and/or escalating any conditions or problems that may affect the quality or integrity of product to supervisor and HOD production.
• 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.
• Understands and adheres to all Company policies, procedures, SOPs and Safety regulations.
• Willingness to do overtime as needed & responsible for performing additional task, related duties as assigned.
• 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.

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Manufacturing

DIVISION: EPD Established Pharma

LOCATION: India
Village Mauza : Baddi

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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