Department

Data Integrity - Quality Control - Microbiology

Location

Zydus Lifesciences Limited, Jarod, Gujarat

Key Responsibilities:

Data Integrity Management

- Ensure compliance with Data Integrity requirements in accordance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available).

- Review microbiology records, logbooks, worksheets, electronic data, and audit trails for compliance.

- Perform periodic Data Integrity assessments and risk evaluations.

- Identify, investigate, and resolve Data Integrity gaps and deviations.

- Support implementation and monitoring of Data Integrity controls in laboratory systems and processes.

Microbiology Laboratory Operations

- Oversee environmental monitoring, water testing, sterility testing, bioburden testing, bacterial endotoxin testing, and microbial identification activities.

- Ensure timely review and approval of microbiological analysis records.

- Support qualification and validation activities related to microbiology laboratories and utilities.

- Ensure adherence to SOPs, GDP (Good Documentation Practices), and cGMP requirements.

Investigation & CAPA Management

- Lead investigations related to OOS (Out of Specification), OOT (Out of Trend), deviations, and Data Integrity events.

- Conduct root cause analysis and implement effective CAPA.





- Monitor CAPA effectiveness and closure within defined timelines.

Regulatory Compliance

- Ensure laboratory practices comply with USFDA, MHRA, EU GMP, WHO, PIC/S, and other applicable regulatory guidelines.

- Support regulatory inspections, customer audits, and internal audits.

- Prepare responses to audit observations and ensure timely closure.

Documentation & Training

- Review and approve SOPs, protocols, reports, and validation documents.

- Conduct Data Integrity and GMP training programs for laboratory personnel.

- Maintain training records and competency assessments.

Continuous Improvement

- Drive initiatives for digitization, process optimization, and risk reduction.

- Participate in quality improvement projects and laboratory excellence programs.

- Support implementation of electronic systems and audit trail review processes.

Educational Qualification

- M.Sc. in Microbiology / Biotechnology / Life Sciences or equivalent.

- Additional certification in GMP, Quality Systems, or Data Integrity will be an advantage.

Experience

- 8 to 12 years of experience in Quality Control Microbiology within a regulated pharmaceutical setting.

- Minimum 2 to 4 years of experience in Data Integrity compliance activities.

- Experience in sterile/parenteral manufacturing is preferred.

📌 Data Integrity (Microbiology), Parenteral Operations (Gujarat)
🏢 zydus
📍 Gujarat