Officer

Purpose

This candidate will primarily be responsible for supervision of shop floor activities of Nasal Manufacturing, filling and autoclaving activities in shifts with close monitoring of throughput along with quality compliance & efficiency in GMP environment.

Position / Job Title

Officer / Sr. officer Filling & Manufacturing.

Department

Nasal Formulation

Reporting To

Sr. Executive / Asst. Manager

Location

Ambernath

Years Of Experience

Officer – 1 to 4 Years

Sr. Officer - 5+ Years

Dosage Form

Nasal Formulation

Job Responsibilities / Deliverables

To Perform & monitor the shopfloor Activities as per the SOP.

To Monitor & track the daily ShiftWise plan as per the target given.

To allocate the manpower in respective areas and should have experience in manpower handling

Supervision of area cleaning, sanitization, equipment cleaning, batch manufacturing, batch filling and autoclaving activities & Online recording of the activity in the BMR/BPR and Logbooks.

Calibration of equipment/instruments on shop floor e.g., weighing balances, Leak test apparatus, PH meter, DO meter, Load cell, Socouge gauge, Digimatic indicator.

Checking and recording of the in-process parameter during manufacturing, filling and autoclaving activity.

Troubleshooting of equipment by coordination with machine technician & engineering department

Monitors rejection and ensures minimal rejections and losses during the filtration, filling, bottle cleaning, assembly and sampling of the bulk.

To ensure safety, hygiene and maintain c-GMP environment during manufacturing, filling and autoclaving process.

To report any incident or violation of GMP act to immediate manager/ shift in charge.

To carry out the activity in an effective manner to achieve departmental objective.

Provide ideas for process optimization and cycle time reduction.

Qualifications & Pre-Requisites

B. Pharm

Must work in Shifts.

Should have good experience in operation of 21 CFR part 11 compliant system and have knowledge of performing CIP, SIP, Pressure hold test and recipe base manufacturing.

Should have good experience in operation of manufacturing and holding equipment preferably Biozeen/Gem pharm/Adam/Praj Hi purity/Anish pharma/DD pharma/life craft / Marchesini / DARA / Strobel/NKP / ROTA / Bosch/Groninger.

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 &CFT.

High level of personal and workplace hygiene and compliance