Aseptic Manufacturing

Role & responsibilities

• Setup Start Batch and operate pharmaceutical production equipment including high-speed device manufacturing lines for medical device assembly, fully automatic packaging line, blister packaging lines, change parts for cartridges and vial packaging processes and inspection line equipment (e.g. Syntegon, Bausch Strobe Filling machine etc.) as per relevant SOPs and the Batch Record.
• Responsible for packaging activities of production batches as per relevant SOPs and the Batch Record. This includes formulation and/or dispensing of all the available Drug product(s) and dispatch.
• Responsible for changeover preparation, dispensing and verification of materials.
• Responsible for packaging and transfer of the final product to cold storage as per relevant SOPs and the Batch Record.
• Complete all the relevant training before executing any task all the time and every time.
• For packaging operations strictly follow GMP techniques and practices practice as per relevant SOPs.
• Carry out the cleaning and upkeep of the production equipment and classified areas in manufacturing area as per relevant SOPs and the Batch Record.
• Timely completion of relevant batch record and logbooks for the tasks performed and with adherence to GDP (Good
  
  Documentation Practice).
• Transfer materials for manufacturing a batch as per relevant SOPs and the Batch Record.
• Provide for the loading/unloading of the loads/batch from the equipment during production activities as per relevant
• SOPs and the Batch Record.
• Perform stock check of consumables and inform
• Follow safety and quality compliance at all times and communicate in a timely manner to the superior if any anomalies are observed.
• Participate in EHS, Business Compliance, cGMP and all other compliance-related matters, where applicable.