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Data Integrity (Microbiology), Parenteral Operations
Vadodara · Staff/Principal
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What we know about this role
HIGH
Zydus Group is actively reviewing profiles and moving candidates through the pipeline right now.
First 72 hours
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Job description
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 environment.
- Minimum 2 to 4 years of experience in Data Integrity compliance activities.
- Experience in sterile/parenteral manufacturing is preferred.
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