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EXECUTIVE/SR. EXECUTIVE CSV

Keywords / Skills : CSV, Computer System Validation, CFR, Part 11, system validation, Risk Assessment, GAMP5, GXP, LIM, Slaboratory information management, laboratory information

3 - 6 years
Posted: 2018-11-09

Industry
Pharmaceutical
Function
IT
Role
System Analyst/ Tech Architect
Posted On
9th Nov 2018
Job Description
Executive/Sr. Executive - CSV ( Computer System Validations)

Job description

Should have experience in validation of various application like Oracle Application, Agile QMS, Agile Pack and Label and TraceLink application

Should have good experience on Infrastructure validation for GxP applications and its supporting documentation

Should have Good knowledge on GAMP 5 Risk based GxP applications validations and its categories with detailed approach

Should have good knowledge on 21 CFR Part 11 and its assessment for various applications

Should have good knowledge on Annexure 11 and its assessment for various applications

Should have knowledge Europe serialisation and its validation including CMO on boarding and its validation

Should have hands on experience in preparation of validation deliverables as per GAMP5 categories

Should have hands on experience in Preparation and execution of test scripts for various qualifications of IQ, OQ and PQ

Should have hands on experience in preparation of Functional Risk Assessment

Should have hands on experience in preparation of System Risk Assessment

Should have hands on experience in preparation of 21 CFR Part 11 assessment and compliance Report

Should have hands on experience in preparation of Annexure11assessment and compliance Report

Should have hands on experience in preparation of Traceability Matrix and Validation Summary Report for various applications

Should have hands on experience in preparation of various supporting SOPs for application, Part 11, Annexure-11 and Infrastructure Qualifications

Should have good knowledge on Change management and patch management process

Should have good knowledge on Periodic Review and schedule, plan, execution and Report for various applications

Should have hands on experience on preparation of MVP and VP

Should have hands on experience in preparation of IQ, OQ and PQ protocols

Should have experience in facing of USFDA audits and internal audits

Should have good communications skills and with good attitude

Should have knowledge on Automation testing Tools like Selenium etc.,

Should have good experience in validation of Trace Link application for Europe or USA implementation

Should have experience in handling of multiple projects with good coordination

Should have experience in LIMS validation and its functionality

Should have experience in QMS application validation and its Maintenance

About Company

Aurobindo Pharma is a fast track integrated pharmaceutical company headquartered in Hyderabad, India, producing and marketing some of the most quality conscious Active Pharmaceutical Ingredients (bulk actives), intermediates and speciality generic formulations.

It ranks among the top 5 pharma companies in India and is a multi product, multi technology, transnational company. Today the Company�s products are serving consumers in India and over 100 other countries.

Aurobindo Pharma is an R&D driven chemistry business house, with a very broad product portfolio. The Company has a presence in fast growing life style disease drugs, anti infective drugs and key speciality therapeutics.

The Company is a known leader in the semi synthetic penicillins and cephalosporins. Indeed, Aurobindo seeks to attain significant market presence in every area of its business. After creating a name for itself in producing APIs and intermediates, Aurobindo Pharma sees major growth in its speciality generic formulations business.

Aurobindo Pharma values its contribution to its customers and the medical profession. The Company has accordingly planned its strategic growth, proactively responded to the changing requirements of the medical profession, and enabled its core customers to meet their market needs

The customers of the Company benefit from the most modern and state-of-the-art manufacturing facilities and a quality conscious approach to business. Aurobindo Pharma believes in delivering value in every transaction.

The Company sees its potential both in regulated and other global markets. In regulated markets, Aurobindo Pharma visualises profits aided by the thrust in building intellectual property. In the large growth segments of other global markets, the Company will succeed by virtue of its cost efficient production.

Volumes have been ensured by expanding capacities in the remunerative/demand pull segments. In turn, this has provided economies of scale. Aurobindo Pharma takes care to remain a quality conscious cost efficient producer.
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