QA Data Intergity Cell

Zydus Lifesciences; Ankleshwar; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Zydus Lifesciences invites experienced data integrity professionals to join the Data Integrity Cell. The role requires 8–10 years of experience and a QC background in chemicals, with hands-on expertise in DI requirements, data review, and audit trails.

You will review chromatographic and non-chromatographic data, ensure 21 CFR Part 11 compliance, and support computer system validation. Strong communication skills are essential to collaborate with cross-functional teams and uphold data integrity

Qualifications

• 8–10 years of experience in data integrity
• Background in QC - chemical preferred
• Experience reviewing chromatography and non-chromatography data
• Familiar with 21 CFR Part 11 and audit trails

Responsibilities

• Review chromatography data and non-chromatography data
• Review audit trails in laboratory software
• Ensure compliance with 21 CFR Part 11
• Support data integrity audits

Skills

DI requirements

Chromatography data review

Non-chromatographic data review

Analytical data review

Audit trail review

21 CFR Part 11

Computer system validation

Good communication

Job description

An opportunity to work with Data Integrity Cell .

Experience - 8- 10 Years .

Background with QC - chemical prefered .

Should Have Sound Knowledge of below

• DI requirements
• Chromatography and non-chromatographic data review. Candidate with knowledge of Chromeleon CDS will be preferred.
• Analytical data review (paper and electronic data)
• Audit trail review of laboratory softwares
• 21CFR Part 11 requirements.
• Computer system validation (added advantage)
• Good communication skills