Role Summary:
We are seeking a detail-oriented and skilled Sterile Filling Operator to join our production team. The role involves working in a cleanroom environment to ensure the manufacture of high-quality sterile pharmaceutical products in compliance with regulatory guidelines (SFDA, GMP, WHO)
Responsibilities:
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Operate sterile filling equipment for ophthalmic/sterile preparations as per SOPs.
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Load and unload materials, containers, and other components required for filling operations.
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Perform sterile cleaning operations and operate automated CIP/SIP systems.
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Maintain contamination-free operations and adhere to cleanroom protocols, including strict gowning procedures.
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Perform operations under ISO 5 (Grade A) and ISO 7 (Grade B) conditions.
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Ensure cleanliness and environmental standards in classified areas.
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Accurately complete batch records and logbooks following SOPs and regulatory guidelines.
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Comply with EHS policies and maintain a safe working environment.
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Perform routine cleaning and sterilization of production areas and equipment.
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Set up, operate, and troubleshoot production equipment, performing minor maintenance and coordinating repairs with maintenance teams.
Qualifications and Skills:
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Diploma in Engineering or related field.
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2–4 years of experience in sterile pharmaceutical manufacturing or aseptic processing.
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Knowledge of GMP, SFDA, and WHO guidelines.
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Understanding of aseptic techniques and sterile processes.
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Strong attention to detail, quality focus, and good teamwork and communication skills.