QA Data Intergity Cell

Zydus Lifesciences

7 - 12 years

5 - 8 Lacs

anklesvar ankleshwar

Posted:1 week ago| Platform:

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Skills Required

data integrity data management data quality data integration

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities

Review SOPs, Checklists, Test procedures, Formats, Master batch records and Laboratory testing worksheets for identification of complex procedures/formats which may lead to deviation with ALCOA+ and take CAPAs for simplification.
Review controls on computerized systems to ensure data generated from these systems is meeting the data reliability requirements.
Review compliance against 21 CFR Part 11 requirements for electronic data generating systems.
Review paper data, electronic data and audit trail of GMP activities at the site to check adherence and compliance level with respect to data reliability requirements.
Perform walkthrough on the shop floor to identify the complexities in the processes which may lead to deviation from ALCOA+, and to take CAPAs as needed.
Review several trends (but not limited to) like GDP error, OOS, deviation and lab incident and identify CAPAs as appropriate to prevent the departure from ALCOA+.
Participate in Daily QUEST dialogue and share the trends related to data reliability.
Perform periodic surveys (related to ALCOA+) from employees, analyze feedback received from survey, and to take CAPAs as needed.
Provide training to employees on the different topics related to data reliability and data security aspects.
Ensure CAPAs as determined are implemented
Perform and Review data integrity risk assessment and Process design at site and ensure implementation of mitigation.
Review of investigations related to data reliability at site.

Preferred candidate profile

Msc Chemistry Preferred

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