17 Sep
|
Rubicon Research
|
India
17 Sep
Rubicon Research
India
:
PurposeThis candidate will primarily be responsible for the operation, cleaning and maintenance of the Filling line, i.e. Bottle cleaning machine, bottle filling and capping machine efficiently in GMP setting. Position / Job TitleSr. Technician / Technician - Nasal FormulationDepartmentNasal FormulationReporting ToSr.
Executive / Asst. Manager LocationAmbernathYears of ExperienceTechnician – 1 to 4 years.Sr. Technician - 5+ YearsDosage FormNasal Formulation Job Responsibilities / Deliverables
- Operation, cleaning and maintenance of the Bottle cleaning machine, bottle filling and capping machine and accessories associated.
- Starts up, operates, shuts down the above listed Bottle cleaning machine, bottle filling and capping machine safe manner in assigned area in accordance with Standard Operating Procedures.
- Performs cleaning of machine and area and does change over from batch to batch or product to product in assigned area in accordance with Standard operating procedures.
- Coordinates with QA to ensure line clearance for equipment and product within specified timelines.
- Responsible for machine settings, challenge tests as per BPR, initial process checks and in process checks like bottle cleaning quality, Fill weight, filled bottle pump placement check, No cap, No dip tube, Leak test etc.
- Keep a watch on any jams in star wheel, filling station, cleaning station, machine malfunctions and alarms and trouble shoot the same related to settings.
Reports to supervisor and engineering team on any mechanical or electrical malfunction.
- Should be able to do trouble shooting of dose variation, capping rejects, Toppling of bottles, Sensor adjustment etc.
- Monitors reject and ensure minimal rejections and losses during the cleaning & filling process.
- Fills BMR/BPR and logbooks online during start up and while in operation for in process.
- Performs calibration of balances and checks for calibration of instruments and preventive maintenance of equipment.
- To ensure safety and hygiene during bulk transfer from holding vessel to buffer vessel, bottle loading and cleaning activity and bottle filling operation.
- To report any incident or violation of GMP act to immediate supervisor.
- To maintain the c-GMP environment in the Manufacturing and filling area.
- Provide ideas for process and Machine improvements.
Qualifications & Pre-Requisites
- D. Pharm/ ITI/DME/DEE
- Must be work in shifts.
- Should have good experience in the operation of hi-tech machines with PLC controls, preferably Groninger / ROTA / Strobel / NKP / Boush / Harshit.
- Candidates can be hired preferably from Cipla / Glenmark / Aurobindo / Dr. Reddy’s / Indoco Remedies / Accent Pharma / Gland / Caplin Point / Lupin / Serum.
Additional notes
- Exposure of regulatory audits -USFDA, MHRA, TGA, ANVISA etc.
- Knowledge of safe acts and behaviors and compliance to safety
- Good communication skills to communicate with coworkers & supervisors
- High level of personal and workplace hygiene and compliance.
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📌 Technician (India)
🏢 Rubicon Research
📍 India