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Baxter Microbiology Associate Job Opening – Apply Online
Sr Assoc, Microbiology
Req #: JR – 158496
Location: Ahmedabad, Gujarat, India
Job Category: Microbiology
Date posted: 01/20/2025
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
- To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and to prepare the media, as and when required. To observe the tubes and plates and to supervise the discarding method of the same.
- To perform periodic microbiological tests as per the schedule, as per Standard Operating Procedure (SOP).
- To perform the Bacterial Endotoxin Test as per the schedule.
- To test the material for their pre-sterile bio-burden and to test Raw Material (RM)/ Packing Material (PM) for bio-burden test.
- To co-ordinate with Technical department for any kind of machine-related abnormality, which might be affecting the quality of the product, and its microbiological content.
- To take the samples for sterility test and to carry out the sterility testing as per schedule.
- To sign all the documents related to microbiological testing.
- To sign the documents related to sterility testing. To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bio-burden, Total Organic Carbon (TOC), bio-assay, pathogens, Thermopiles, chlorides, hardness, silt density index, etc.
- To analyze the samples of water system after maintenance work and forward the report to executive of department for review.
- To maintain and update stock record of Limulus Amoebocyte Lysate (LAL) reagents.
- To qualify the personnel to enter into the clean room. To keep track of requirements for procurement and give monthly requirement to executive.
- To qualify the prepared media for growth promotion test. To perform gram staining of daily-observed colonies and identify them on BBL crystal.
- To perform the microbiological analysis of stability samples as per daily plan of work and in line with standard operating procedure.
- To prepare contact plates for routine monitoring. To perform the validation as per the laid-down protocol.
- To prepare pure culture for routine use. To maintain and update media stock record formats.
- To record all the data related to microbiological testing.
- To prepare a requirement list of media & reagent for procurement.
- To intimate the executive for any abnormalities in microbiological analysis. However, in the absence of the executive, intimate the status of the same to the Department Head.
- To ensure a clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per international standards and guidelines.
- To do sampling of Water for Injection (WFI), double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), raw water, and pure steam.
- To collect the validation samples as per validation protocol.
- To prepare trends of the results obtained.
- To qualify the personnel to enter into the clean room.
- To perform HEPA filter qualification on a periodic basis and as and when required.
- To operate laboratory instruments or equipment as and when required.
- To initiate non-conformity or Out of Specification in case of abnormality observed.
- To perform data entry for trend analysis of the daily result observed.
- To communicate any failure or abnormal notification to the respective Supervisor for their attention and to seek the solution.
- To bring to the notice of the Supervisor about the abnormalities in the clean room or manufacturing areas and suggest the preventive and corrective measures in case of such abnormalities as per the guideline.
Skills Required – Functional/Behavioral:
- Aseptic Processing and Sterile Product Processing Technologies
- Ability to Exchange Constructive Feedback
- Product and Process Familiarity
- QMS Events
- Quality Systems and GMP Compliance Knowledge
- Regulatory Knowledge and Liaison Understanding
Keywords: Microbiology job, Sr Assoc, Baxter, Ahmedabad, Gujarat, India. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebo
