Job Opening in Data Integrity Cell/quest Team

7 days ago

Ahmedabad Gujarat, India Zydus Group Full time

Department
- BIOLOGICS - II QA
- Job posted on
- Feb 05, 2025
- Employment type
- C-C8-Confirmed-HO Executive

Experience : 9-10 years

Qualification : M.Sc. - Chemistry/ Organic Chemistry / Biotechnology / Microbiology

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 CAPA’s 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.
- Distribution of Rewards and Recognitions to employees as and when required.
- Communicate identified discrepancies to responsible personnel at the site and Head QUEST and Data Integrity Cell and ensure the compliance along with review of compliance report from site and its effective implementation.
- Any other activities assigned by Head QUEST and Data Integrity Cell to support other functions/activities.

Sound knowledge of:

- DI requirements.
- Analytical data review (paper and electronic data)
- Audit trail review of laboratory softwares
- Analytical techniques (Chromatography and non-chromatography techniques)
- 21CFR Part 11 requirements.
- Computer system validation (added advantage)
- Good communication skills

Background : Quality Control (Chemical)

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