Executive

Lupin Ltd

Goa

Presencial

INR 600.000 - 850.000

Jornada completa

hace 11 horas

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Descripción de la vacante

Lupin Ltd in Goa is seeking a QA-focused professional with 4–6 years of experience in pharmaceutical production and IPQC/KQA practices. Responsibilities include in-process sampling, hold-time studies, instrument calibration, and thorough document review.

The role involves line clearances, batch record approvals, and PAS-X system activities. Education required: Graduation in Pharmacy and Post Graduation in Pharmacy.

Formación

In-process sampling and testing knowledge.
Experience with holding time studies and sampling in production.
Familiarity with ICHQA/QA deviations and record observations.

Responsabilidades

In-process sampling and testing.
Finished product sampling (bulk finish and packed samples).
Hold time study execution and sampling at hold time stage.
Quality Assurance rounds to note deviations and record observations.
Maintenance of instruments (IPQC & routine calibration).
Review log books and environmental monitoring files.
Online review of equipment usage, cleaning records and calibration logs.
Line clearances for production activities.
Release/approval of BRRs/ESPs in PAS-X.
Release/approval of batch manufacturing and batch packing records.
Participate in equipment qualifications.
Execution of cleaning validation and equipment qualification.

Conocimientos

IPQC

Quality Assurance

Documentation

Calibration

Educación

Graduation in Pharmacy

Post Graduation in Pharmacy

Herramientas

PAS-X System

Descripción del empleo

Job Description

Finished product sampling (Bulk finish and Packed samples).
Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
Conducting the round of Quality Assurance to note down any deviations from the systems/ SOPs etc. and record the observations.
Maintenance of instruments in the IPQC & routine calibration.
Review log books and environmental monitoring files.
Online review the different records such as equipment usage and cleaning records, area usage record, balance calibration records etc.
Line clearances for different activities in the Production Department.
Execution, Review and Release/Approval of documents like BRRs, ESPs in PAS-X System.
Execution, Review and Approval of batch manufacturing records and Batch Packing records.
Participate in equipment qualifications as per the requirements.
Execution of cleaning validation & equipment qualification.

Job Description

In-process sampling and testing.
Finished product sampling (Bulk finish and Packed samples).
Hold time study execution and sampling at hold time stage, bulk finished and packed samples.
Conducting the round of Quality Assurance to note down any deviations from the systems/ SOPs etc. and record the observations.
Maintenance of instruments in the IPQC & routine calibration.
Review log books and environmental monitoring files.
Online review the different records such as equipment usage and cleaning records, area usage record, balance calibration records etc.
Line clearances for different activities in the Production Department.
Execution, Review and Release/Approval of documents like BRRs, ESPs in PAS-X System.
Execution, Review and Approval of batch manufacturing records and Batch Packing records.
Participate in equipment qualifications as per the requirements.
Execution of cleaning validation & equipment qualification.