Job description:
Operate and monitor granulation equipment and related manufacturing apparatus in accordance with validated procedures and GMP standards.
Supervision of Mfg activities (Equipment like RMG,FBE,FBD,RMG 800)
To perform PQ for any new equipment’s / system.
Ensure execution of daily activities and documentation along with operator for processing area such as Temperature / %RH, area cleaning, balance verification, calibration.
Handle raw materials, intermediate products, and finished goods with care to maintain product quality and prevent cross-contamination.
Perform granulation and blending operations for tablet granulations and capsule powders per approved batch manufacturing records.
Mix and compound ingredients for liquid products, suspensions, ointments, and granulations per approved formulations as required.
Conduct general maintenance on granulators, blenders, homogenizers, and related equipment to ensure operational readiness.
Execute Standard Operating Procedures and maintain accurate batch documentation records in compliance with cGMP requirements.
Ensure all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines.
Participate in functional team projects focused on developing process improvement methods to enhance quality, cost efficiency, and scheduling.
Support area cleaning and sanitization activities to maintain a compliant and safe manufacturing environment.
Additional Responsibilities :
Education:
Experience:
Specialized Knowledge: Licenses:
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