Pharmaceutical Manufacturing Operator
1 week ago
Job description
Work Hours/ Shift
These are full-time positions, paid on an hourly basis, eligible for paid time-off and benefits for the following shifts:
Shift 1 - 7:00 AM – 3:30 PM
Shift 2 - 3:00 PM – 11:30 PM
OT required mornings and weekends.
Skills/ Competencies
- Must have legible handwriting, and the ability to perform accurate documentation.
- Understanding of granulation, compression, coating, and encapsulation machines.
- Capable of conducting troubleshooting, investigations and root cause identification and analysis.
- Able to prioritize, plan and work under tight schedules and deadlines.
- Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.
- Must communicate clearly and concisely across levels, both orally and in written.
- Strong command over written and verbal English is required.
Responsibilities/ Accountabilities
- Must be willing to work in a pharmaceutical manufacturing setting.
- Must be able to know how to operate pharmaceutical production machinery independently and thoroughly complete required documentation (legible writing, accurate reporting, maintain and file, etc.)
- Execute procedures for manufacturing processes in accordance with batch manufacturing record (BMR) and Standard Operating Procedures (SOP) requirements.
- Perform machine changeovers, cleaning and set up as per SOPs. Ensure the proper area & equipment cleanliness and setup in stipulated time.
- Prepare a room and equipment for line clearance, replace room filters, Ensure verification and calibration of balance/scale and check pressure differential for the rooms.
- Ensure line clearance before initiating manufacturing activities in each area.
- Receive/transfer material from/to dispensing/manufacturing storage and check dispensed materials/final mix blend/compressed tablets and labeling as per BMR.
- Wear appropriate personal protective equipment (PPE) as stated in the SOP/BMR before initiating the process.
- Able to operate applicable equipment independently as per area of operation.
- Ensure adherence to quality standards during all stages of the manufacturing process.
- Complete manufacturing documents on time, ensuring accuracy and completeness.
- Responsible for training on all relevant SOPs and always maintain compliance with related SOPs and current Good Manufacturing Practices (cGMP) in the manufacturing process.
- Perform duties through the proper, safe use of equipment, according to Health & Safety procedures and Equipment Manuals.
- Flexible to work extended hours, to achieve manufacturing schedule when needed.
- Maintain discipline and comply with company policies and procedures.
- Perform entire duties as communicated time to time by department management/designee.
- Participate in safety related programs and or safety teams as needed.
- Enforce and follow safety regulations and ensure the working area is clean.
- Adhere to Safety, Health, and Environmental policies.
- Must be able to work under general supervision and able to work independently and in a team environment.
- Must be able to exercise appropriate professional judgment on matters of significance.
- Other duties assigned as required by Manufacturing Management.
Education Qualifications
- High School Diploma or equivalent experience
Minimum three years of direct work experience in pharmaceutical manufacturing. Preference will be given to candidates with experience in generic pharmaceutical manufacturing.
Physical Requirements
- Should not have any restriction to work with powder containing active pharmaceutical ingredients.
- This position requires the ability to do heavy lifting / bending frequently.
- Long periods of standing up/walking during the working hours; ability to ascend/descend ladders; and able to lift to 35 pounds.
- Must be able to move pallets/equipment weighing about 200 – 300 kgs using suitable moving equipment like pallet jacks.
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