Lab QA (QA in QC , Micro SME)

Zydus Group; Ahmedabad District; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Zydus Lifesciences in Moraiya, Gujarat, is seeking a Senior Executive for Microbiology QA. The role requires 7–10 years of experience with Zydus in India and strong expertise in MLT testing, validation, and environmental monitoring, to ensure daily compliance in the QC microbiology lab.

You will review laboratory documents, SOPs, and QMS records; participate in investigations of microbial excursions; and support QA with software tools like Documentum, LIMS, eLIMS, and DMS in a fast-paced

Qualifications

• Monitoring of the compliance in the Microbiology Laboratory of Quality Control.
• LeadQA SME for Microbiology to ensure daily compliance of the laboratory operations.
• Review of Microbiology Lab documents, reports such as Sterility test, BET, MLT related to FP, RM and stability samples.
• Review the documents of Microbiologist qualification, method validation, and disinfectant efficacy test.
• Review of SOPs, Specification, Trends of Environmental monitoring and Water, Validations / Qualification of an equipment and instrument.
• Participate in the investigation of microbial excursion in microbiological lab.
• Review and evaluation of QMS documents like Deviation, Change controls, CAPA ,Incident in microbiology lab.
• Daily monitoring of lab activities and recording of QA observations.
• Review of microbiology department instruments Software audit trials.
• Issuance and reconciliation of forms and formats through Documentum Software.
• Review of all microbiological related documents before submitting to IRA.

Responsibilities

• Monitor compliance in the Microbiology QA laboratory and report roadblocks.
• Lead QA SME activities for microbiology to ensure daily lab compliance.
• Review sterility, microbiology reports and related samples for FP, RM and stability.
• Validate microbiology documents, methods and disinfectant efficacy tests.
• Review SOPs, specs and environmental monitoring trends; validate equipment qualifications.
• Investigate microbial excursions and document findings in QA records.
• Assess Deviation, Change controls, CAPA and incidents in microbiology QA.
• Daily QA observations and recording of lab activities.
• Audit trials for microbiology instruments and software logs.
• Prepare and reconcile forms via Documentum; ensure proper documentation before IRA submission.

Skills

MLT testing

validation

GPT

EM

culture identification

PET

DET

LIMS

eLIMS Track wise

DMS

basic computer applications

Tools

Documentum Software

Job description

Manufacturing-formulation|for.mfg.moraiya, Ahmedabad, Gujarat, India

7 - 10 Years

Job Description

Position: Senior Executive

Report to: Lab QA Head

Department: Quality Assurance

Location: Moraiya

Requirements:

Year of Experience: 7-10 years

Experience in Zydus: Minimum of 2 years in the same role at any formulation manufacturing site of Zydus in India. (minimum 2 performance rating in the current role)

Technical skills required :MLT testing, validation, GPT, EM, culture identification, PET, DET

Soft skills required : LIMS,eLIMS Track wise, DMS and basic computer applications.

Qualification:

• Monitoringof the compliance in the Microbiology Laboratory of Quality Control.
• LeadQA SME for Microbiology to ensure daily compliance of the laboratoryoperations.
• Reviewof Microbiology Lab documents, reports such as Sterility test, BET, MLTrelated to FP, RM and stability samples.
• Reviewthe documents of Microbiologist qualification, method validation, anddisinfectant efficacy test.
• Reviewof SOPs, Specification, Trends of Environmental monitoring and Water,Validations / Qualification of an equipment and instrument.
• Participatein the investigation of microbial excursion in microbiological lab.
• Reviewand evaluation of QMS documents like Deviation, Change controls, CAPA ,Incident in microbiology lab.
• Dailymonitoring of lab activities and recording of QA observations.
• Reviewof microbiology department instruments Software audit trials.
• Issuanceand reconciliation of forms and formats through Documentum Software.
• Reviewof all microbiological related documents before submitting to IRA.

Job Snapshot

Updated Date

21-10-2026

Job ID

JOB11208

Department

MORAIYA QA

Location

Location Manufacturing-formulation|for.mfg.moraiya, Ahmedabad, Gujarat, India

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.