Lab QA (QA in QC , Micro SME)

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.