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Assistant Manager Computer Validation


Source:
TIMESJOBS.COM
Location:
Chennai, TN
Date:
13-11-2016
Job Code:
58266102
Categories:
  • Biotechnology & Science
Applying for this job will take you to an external site
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Job Details

Responsible for end to end Computer System Validation and Qualification.Responsible for supporting key strategic initiatives on CSV, APCs and spread sheets.Must demonstrate a strong working knowledge of Regulatory Expectations on Computer System Validation (CSV).Responsible to resolve simple, moderate & complex issues related to computer validation and also identify avenues for continuous improvement.Responsible to align the Site procedures with corporate SOPs.Preparation and mandatory review of departmental SOP s (related to CSV), also give required training to the users.End to end responsible for computer system qualification and keep the facility ready for Regulatory Audits.Knowledge and SkillsTechnical Skills Knowledge of Computer system used in manufacturing organizationsWell versed with latest guidelines 21CFR Part 11 and GAMP5.Standards, Processes and PoliciesBasic understanding of cGMP and good documentation practices in pharmaceutical IndustryBehavioural / Any other Skills Good English writing skillsCommunication skillsInter personal skills
Additional Degree: BE/ B.Tech (Engineering)

Experience: 8-12

Requirements

Business/Systems Analysis | System Administration | System Analyst/Tech Architect
Applying for this job will take you to an external site

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