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 -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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 the 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, labelling 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 substance(s) 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 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.
• Prepare filters for test execution and perform FIT (filter Integrity testing) 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 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 the standard operating procedures and maintain strict compliance to GMP at all times. Report all the quality issues immediately to Manager or Lead technician.
•  Any other duties as and when 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 experiences in 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 pharmaceutical Industry.
• Able to work as a team.
• Able to work rotating shift.