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Lab QA (QA in QC , Micro SME)

AhmedabadOn-siteStaff/Principal

Good timing - competition is buildingPosted 6d ago

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  • Not a repost. 8 of Zydus Group's last 38 posts were reposts; 11 of its 19 open roles are here.

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The job post

248 words · from Zydus Group's careers site

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 Job description:

·       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.

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