Overview

Head & AGM Microbiology – Sterile Jobs in Nālāgarh, Himachal Pradesh, India at Immacule Lifesciences

Location: Nālāgarh

Responsibilities:

Responsible for preparation of validation /qualification protocol, execution of validation activities and review of report of microbiological methods in the microbiology lab.

Responsible for ensuring the testing and releasing of raw material, packing material and finished product from microbiology laboratory as per defined procedure and reviewing the result.

To monitor the sample management system and planning of testing of raw material, in-process sample, packing material and finished product.

Responsible for reviewing the records of in-process release of product i.e. bioburden analysis antibiotic assay, biological indicators and packing materials.

To review the documents related to finish product release i.e. sterility test and bacterial endotoxin test and microbial limit test.

Responsible for receipt of raw material, in-process, miscellaneous and finished sample from the production blocks, making entries in the sample receipt records and planning of sample analysis accordingly.

Managing deviations, change control, incidences with investigation and associated CAPA.

Investigation of OOS in the laboratory and associated CAPA.

Responsible for preparation of standard operating procedure, validation protocol and execution.

Responsible for the participation in media fill activity as per planning.

Responsible for planning and qualification of microbiologist for various testing done in microbiology Laboratory.

To impart training to the subordinates as per requirement in the company.

To participate in training programs organized by the company.

To ensure that cGLP norms are followed while performing analysis.

To maintain the inventories of the lab as per requirement.

Verification of material indent request.

Responsible for planning and reviewing of environmental monitoring programme.

Responsible for compliance of microbiology lab.

Title: Head & AGM Microbiology – Sterile

Company: Immacule Lifesciences

Location: Nālāgarh, Himachal Pradesh, India

Category: Healthcare (Data Scientist), Quality Assurance – QA/QC

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