Manufacturing Operator II
- Operate pharmaceutical production machinery independently.
- Execute manufacturing processesin accordance withBatch Manufacturing Records (BMR) and Standard Operating Procedures (SOPs).
- Perform machine changeovers, cleaning, and setup as per SOPs; ensure proper area and equipment cleanliness within stipulated time.
- Prepare rooms and equipment for line clearance, replace room filters, verify and calibrate balances/scales, and check pressure differentials.
- Ensure line clearance beforeinitiatingmanufacturing activities in each area.
- Receive and transfer materials between dispensing and manufacturing storage; check dispensed materials, final mix blend, compressed tablets, and labeling as per BMR.
- Wearappropriate personalprotective equipment (PPE) asstatedin SOP/BMR beforeinitiatingprocesses.
- Ensure adherence to quality standards during all stages of the manufacturing process.
- Complete manufacturing documentation accurately and on time.
- Maintain compliance with SOPs and current Good Manufacturing Practices (cGMP) throughout the manufacturing process.
- Operate equipment safely according to Health & Safety procedures and equipment manuals.
- Participate in safety-related programs and/or safety teams as needed.
- Enforce and follow safety regulations andmaintaina clean working area.
- Adhere to Safety, Health, and Environmental policies.
- Perform otherduties asassigned by Manufacturing Management.
- High School Diploma (or equivalent).
- Minimumthree(3) years of direct work experience in pharmaceutical manufacturing.
- Experience in generic pharmaceutical manufacturing preferred.
- Understanding 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.
- Mustpossessstrong documentation and technical writing skills.
- Must be able to clearly communicate in English (verbal and written).
- Frequently lift, bend, and carry up to 35 lbs. throughout the shift.
- Stand or walk for extended periods; climb ladders as needed.
- Use pallet jacks to move up to 200-300kg of equipment and materials.
- No restrictions on working with powdercontainingactive pharmaceutical ingredients.
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