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Job Description
About us
Baxter:
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Why Baxter?
A Career That Matters
Baxter employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
We have following below opening at our plant based at Ahmedabad.
Position Name : Sr. Analyst / Analyst QA (Micro)
Function : Quality Assurance ( QA )
Business Unit : Manufacturing Facility, Ahmedabad
Business Entity : Baxter Pharmaceuticals India Private Limited (Formarly known as Claris Injectables Private Limited)
Job Responsibilities:
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 ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all Day to day checking of records like clean room monitoring, sterilization records, etc. related to microbiology and microbiological testing. Monitoring and preparing the trend through environment monitoring plan through various methods like, Air particulate counts, Microbial air sampling (MAS), Settle plates (SP), Contact plates and swab test and finger dabs, etc. and qualifying the area, based on the results. Monitoring the Water for injection loop system, testing of Single Pass Reverse Osmosis, Double Pass Reverse Osmosis sample and Pure Steam. Preparing the Standard Operating Procedure and recording of various data after verifying it. Preparation of location chart and maintenance of it for the environmental monitoring in the plant. Preparation of the Standard Operating Procedure and Protocol related to equipments for microbiological area, as well as their validation and calibration of it as per the frequency and maintenance of such instruments. Procuring the required material for the microbial testing and environmental monitoring. Preparing and monitoring the trend analysis files for all the data related to environmental monitoring and water system. Ensuring autoclave preparation & cleaning procedures. Colony counts of MAS & SP, and Total viable counts of Micro organisms, Growth Promotion Test (GPT) as well as Validation of products and Media Preparation
Desired Skills & Experience: The candidate must have
2 - 6 years of experience in Micro department of Pharmaceutical industry, preferably in injectable products.
Educational Qualifications : Msc / B. Pharm / M. Pharm
Personal Attributes and skills : The candidate should have
Good communication and interpersonal skills, Ability to manage multiple responsibilities Attention to details and team player
Disclaimer:
Baxter is an equal opportunity employer and makes employment decisions without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other status protected by law.
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