Pharmaceutical Technician II

Work Schedule

12 hr shift/nights

Environmental Conditions

Able to lift 40 lbs. without assistance, 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.), Will work with hazardous/toxic materials

Job Description Job Title: Pharmaceutical Technician IIReports to: Operations Manager

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.