Purpose

This candidate will primarily be responsible for the operation, cleaning and maintenance of the Vial / Device Packing machines & Serialization i.e. Labelling, Blister Packing, Temper Evident & Cartonator efficiently in GMP environment.

Position / Job Title

Sr. Technician / Technician - Nasal Formulation

Department

Nasal Formulation

Reporting To

Sr. Executive / Asst. Manager

Location

Ambernath

Years Of Experience

Technician – 1 to 4 years.

Sr. Technician - 5+ Years

Dosage Form

Nasal Formulation

Job Responsibilities / Deliverables

Operation, cleaning and maintenance of the Labelling, Blister Packing, Temper Evident & Cartonator, Pharmacode scanning and accessories associated.

Starts up, operates, shuts down the above Labelling, Blister Packing, Temper Evident & Cartonator, Pharmacode scanning in 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 & In process checks as per BPR.

In Checkweigher - like less/more weight,

In Labelling - Wrong Pharmacode, Without a label bottle, Label quality, OCR.

In Cartonator - Without booklet, without bottle, No Carton, Wrong Pharmacode, Missing overprinting, Qty. of bottle in carton.

In Blister – Device presence / absence, Presence /Absence of leaflet, Device actuation sensor Test.

In Track n Trace – Improper 2D code and human readable printing.

Ensures start up and operations of serialization and aggregation system (includes batch creation, batch number download, operations & batch closure). Also he will be responsible for product creation and troubleshooting (Jekson)

Keep a watch on any jams in Checkweigher and Cartonator star wheel, Labelling belt, carton pusher 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 checkweigher, labelling, Cartonator, Track n Trace , Blister machines.

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 robotic and PLC controls, preferably Marchesini, Brothers labeler / Accupack / Pampack / IMAPG / IC-150 / CAM / CVC Labeler.

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.