Job Description :

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 Title:Pharmaceutical Technician II

Reports to:Operations Manager

Responsibilities

Setup and operate pharmaceutical production equipment including high-speed filling lines for sterile products,Autoclave, parts and vialwashers,depyrogenationtunnel, Formulation process,HMI and automatic CIP/SIP processesandinspection and packaging line equipment (e.g.AVIM, labelling and carton machine etc.)as per relevant SOPs and theBatch Record.

Responsible for formulation activities of production batches as per relevant SOPs and theBatch Record.This includes formulation and/or dispensing of all the available Drug substance(s) and excipients.

Responsible for Parts preparation,washingand sterilization of materials.

Responsible for packaging andtransfer ofthe final product to Freezeras per relevant SOPs and theBatch 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 practiceas per relevant SOPs.

Carry out the cleaningand upkeep ofthe production equipment and classified areas in manufacturing areaas per relevant SOPs and theBatch Record.

Timely completion of relevant batchrecordand logbooks for the tasks performedand with adherence toGDP (Good Documentation Practice).

Transfer materials for manufacturing a batchas per relevant SOPs and theBatch Record.

Prepare filters for test executionand perform FIT (filter Integrity testing)as per relevant SOPs and theBatch Record.

Provide forthe loading/unloading of the loads/batch from the equipment during production activitiesas per relevant SOPs and theBatch Record.

Perform stock check of consumables and inform Manager/Lead technician for required materials.

Follow safety and quality compliance at all timesand communicatein a timely mannerto the superior if any anomalies areobserved.

Participate in EHS, Business Compliance,cGMPand all other compliance-related matters, where applicable.

Perform all tasksin accordance withthe standard operating procedures andmaintainstrict compliancetoGMP at all times.Report all the quality issuesimmediatelytoManageror Lead technician.

Any other duties as and when assigned by the Manager.

Perform visual inspection,labelingand packaging onfinished drug products.Perform in-process sampling on semi-finished drug products.Conduct in-process inspection and checks.

How will you get here

Education

MinimumO Level, NITEC/ITEeducation/Diploma in relevant field.

Experience

1to2 years of relevantexperiencesinpharmaceuticalindustry.

3 to 5years ofworkingexperience in anyindustry.

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 rotatingshift.