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Senior Manager For CQA-DA @ Rudraram

Senior Manager For CQA-DA @ Rudraram

MSN Group

13 - 18 years

12 - 16 Lacs

Hyderabad

Posted:3 months ago| Platform:

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Skills Required

Csv ITQA Digital Automation Computer System Validation

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Work from Office

Job Type

Full Time

Job Description

Job Description: We are looking for an experienced IT Quality Assurance (ITQA) Lead to join our team in a regulated pharmaceutical environment. The ideal candidate will have strong expertise in IT quality frameworks, computer system validation (CSV), and digital automation within reputed pharmaceutical companies. Key Responsibilities: Lead qualification and validation of various applications such as DMS, QMS, LMS, LIMS, etc. Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, GAMP 5 , and other relevant regulations. Develop and review Standard Operating Procedures (SOPs) and policies related to CSV. Conduct IT risk assessments and implement best practices for data integrity . Support internal and external audits (FDA, EU, WHO, TGA, etc.) for IT system compliance. Train and mentor IT and QA teams on GxP-compliant system validation . Requirements: 15-18 years of experience in ITQA/Digital Automation within a pharmaceutical company. Strong knowledge of IT quality frameworks and compliance regulations . Hands-on experience in computer system validation (CSV) . Expertise in managing IT audits and regulatory inspections . Excellent leadership and communication skills.

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MSN Group

www.msn-group.com

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Tech City

200 Employees

74 Jobs

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Senior Manager For CQA-DA @ Rudraram

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Senior Manager For CQA-DA @ Rudraram

Experience & Salary

Skills Required

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