Officer/Sr. Officer-QA

Stellar Formulations

Silvassa

On-site

INR 450,000 - 700,000

Full time

5 days ago

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Job summary

Stellar Formulations in India seeks a QA/IPQA professional to ensure GMP compliance, review BMRs, SOPs and validation documents, and oversee QA activities across dispensing, production and packing.

The role emphasizes in-process sampling, IPQA in warehouse and production areas, timely documentation, change control reviews, CAPA, and readiness for inspections.

Responsibilities

Line clearance in dispensing and production area.
To perform in-process sampling, testing and document the observations.
To handle IPQA activity in warehouse and production area.
Review of BMR, process documents etc.
APR Preparation.
To ensure timely validation of production equipments w.r.t. process, cleaning and to collect samples for cleaning validation etc.
To identify problem areas in manufacturing and report to Head QA.
To follow GMP and ensuring timely documentation of dispensing, manufacturing and packing activity.
To oversee the QA activities.
To maintain QA documents in compliance status.
Review of SOPs, BMR, qualification / validation documents.
Maintain the plant equipments in validated status.
Involve in Risk assessment process.
Review of change control, deviations, CAPA, incidents, OOS, OOT, market complaints etc.
To maintain GMP compliance in the plant and ensure all time readiness of facility for inspection.
Identify problem areas and report to Head-Quality.

Job description

Role & responsibilities

Line clearance in dispensing and production area.
To perform in-process sampling, testing and document the observations.
To handle IPQA activity in warehouse and production area.
Review of BMR, process documents etc.
APR Preparation.
To ensure timely validation of production equipments w.r.t. process, cleaning and to collect samples for cleaning validation etc.
To identify problem areas in manufacturing and report to Head QA.
To follow GMP and ensuring timely documentation of dispensing, manufacturing and packing activity.
To oversee the QA activities.
To maintain QA documents in compliance status.
Review of SOPs, BMR, qualification / validation documents.
Maintain the plant equipments in validated status.
Involve in Risk assessment process.
Review of change control, deviations, CAPA, incidents, OOS, OOT, market complaints etc.
To maintain GMP compliance in the plant and ensure all time readiness of facility for inspection.
Identify problem areas and report to Head-Quality.