Aurobindo Pharma Microbiologist Job Opening – Apply
Aurobindo Pharma Microbiologist Job The Aurobindo life family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife’s aim is to provide healthcare at economical prices
Job Title: Microbiologist
Job Location: US-NJ-East Windsor
Job Overview
The Microbiologist will be responsible for performing microbiological testing of cGMP controlled areas, pharmaceutical grade water, and in-process materials in compliance with cGMP, GLP, USP, guidelines and SOPs. The Microbiology may execute 90% – 100% of their work at the bench level.
Responsibilities
Aurobindo Pharma Microbiologist Job
- Preparation of SOP and ensuring of their implementation.
- Provide microbiological sampling, testing, and monitoring to assure quality of materials, components, in-process products, finished products, and retained/stability samples, including a. Media Preparations b. Plate Observations c. Colony identification d. Isolate Library e. Culture Prep and Maintenance f. BET testing g. Sterility testing h. Growth promotion testing (GPT) i. Water / Bioburden testing / MLT / Identification for Microorganisms. j. Environmental Monitoring / Cleaning / Validation, etc.
Preparation of Microbiological method development and method validation procedures like BET Sterility, MLT, BIO Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation. - Microbiological data Review, summary preparation (trend data, test reports and validation data) and Approval of Documents and Procedures.
- Aurobindo Pharma Microbiologist Job Report, investigate, and resolve any QMS incidents in the process, system, facility or documents associated with non-conformances related to the microbiological aspects such as sterility, bioburden, endotoxin, environmental monitoring, etc
- Procurement of Laboratory needs (Laboratory Indent) and qualification of vendors.
Preparation of Validation Protocols and Execution of the same. - Involvement and execution of process simulation studies (Aseptic media fill).
- To ensure the process of Technology Transfer Dossier (TTD) acceptance to the plant and to work out the manufacturing and availability of the product without delays.
Schedule training and qualification of production personnel and their record maintenance. - Handling of OS and OOT.
- Implementation of QMS (Change Management and deviation management in coordination with QA department.
- Execution of equipment and area qualifications.
- Internal inspection for audit compliance.
- Perform troubleshooting and investigations under the direction of a supervisor.
- Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
Qualifications – Skills & Requirements
Aurobindo Pharma Microbiologist Job
- Must possess proven understanding of SOPs and cGMP guidelines and regulations. Aseptic gowning certification desired
- Must possess excellent communication (oral and written), organizational, and interpersonal skills.
- Detail-oriented with strong aseptic techniques and documentation skills.
- Ability to follow SOPs and cGMP guidelines and regulations is required.
- Must be able to work in a team environment and perform job responsibilities under minimal supervision.
- Must be proficient with MS Office applications.
Education & Experience
Minimum Bachelor’s degree in microbiology, and 3-5 years of related lab experience; or equivalent combination of education and experience.
