Pharmaceutical Technician II

Work Schedule

12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. allowed. Cold Room/Freezers: −22°C (−6°C). No contact lenses allowed; prescriptive glasses will be provided. Office. Will work with hazardous/toxic materials.

Job Description

What will you do?

The incumbent will perform various tasks and activities listed below for which they are appropriately trained and are in compliance with the cGMP, company and department SOPs and safety regulations.

Responsibilities

• Setup and operate pharmaceutical production equipment including high-speed filling lines for sterile products, autoclave, parts and vial washers, depyrogenation tunnel, formulation process, HMI and automatic CIP/SIP processes and inspection and packaging line equipment (e.g., AVIM, labeling and carton machine, etc.) as per relevant SOPs and the Batch Record.
• Responsible for formulation activities of production batches as per relevant SOPs and the Batch Record. This includes formulation and/or dispensing of all the available drug substances and excipients.
• Responsible for parts preparation, washing and sterilization of materials.
• Responsible for packaging and transfer of the final product to freezer as per relevant SOPs and the Batch Record.
• Complete all the relevant training before executing any task, all the time and every time.
• For aseptic operations strictly follow aseptic techniques and practices per relevant SOPs.
• Carry out the cleaning and upkeep of the production equipment and classified areas in the manufacturing area as per relevant SOPs and the Batch Record.
• Timely completion of relevant batch records and logbooks for the tasks performed, with adherence to GDP (Good Documentation Practice).
• Transfer materials for manufacturing a batch as per relevant SOPs and the Batch Record.
• Prepare filters for test execution and perform FIT (filter integrity testing) as per relevant SOPs and the Batch Record.
• Provide loading/unloading of loads/batch from the equipment during production activities as per relevant SOPs and the Batch Record.
• Perform stock check of consumables and inform Manager/Lead technician for required materials.
• 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.
• Perform all tasks in accordance with standard operating procedures and maintain strict compliance to GMP at all times. Report all quality issues immediately to Manager or Lead technician.
• Any other duties as assigned by the Manager.
• Perform visual inspection, labeling and packaging on finished drug products. Perform in-process sampling on semi-finished drug products. Conduct in-process inspection and checks.

How will you get here?

Education

• Minimum “O” Level, NITEC/ITE education/Diploma in relevant field.

Experience

• 1 to 2 years of relevant experience in the pharmaceutical industry.
• 3 to 5 years of working experience in any industry.

Knowledge, Skills, Abilities

• Good understanding of safe working practices and cGMP.
• Highly motivated to work in the pharmaceutical industry.
• Able to work as part of a team.
• Able to work rotating shifts.