Job Description

Job summary
We are looking for an individual to execute downstream/upstream manufacturing unit operations, ensuring documentation and compliance within GMP (Positive Manufacturing Practices), regulatory, and organizational guidelines. The objective is to produce products within defined volumes and timelines while maintaining compliance with quality standards, GMP, and other regulatory and statutory requirements, as per the schedule.

Roles & Responsibilities
• You will execute unit operations within Upstream according to the BPR (Batch Production Record), conduct activities to support production schedules, obtain and stock supplies as required, prepare media, buffers, and solutions necessary for unit operations, and perform routine cleaning and support activities in GMP Manufacturing areas.
• You will perform routine process area cleaning, autoclave operation, manual cleaning and sterilization of components and parts, monitoring processes and results, suggesting methods to ensure process success, and interfacing with process automation systems.




• You will issue discrepancies, collaborate with cross-functional departments to close them, implement corrective actions, and comply with GMP and safety standards, for designated manufacturing equipment.
• You will complete batch documentation in alignment with GMP, ensuring data collection and maintenance meet cGMPs (Current GMP), company standards, policies, and regulatory requirements, and supporting timely root cause investigations and CAPA (Corrective and Preventive Actions) completion.
• Your other responsibilities include maintaining manufacturing equipment for correct functionality and calibration compliance, operating within validated process parameters, and supporting qualification and validation activities.
• Emphasizing safety awareness and continuous improvement, you will actively adhere to safety rules and promptly report unsafe matters and near misses/accidents.

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