Job Details:

Role: Lab QA (QA in QC , Micro SME)

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:

M.Sc/B.Pharma

Key :

· Monitoring of the compliance in the Microbiology Laboratory of Quality Control.

· Lead QA 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.

📌 Lab QA (QA in QC , Micro SME) (Ahmedabad)
🏢 Zydus Group
📍 Ahmedabad