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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
Requirements:
To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards
To enumerate and report the tubes and plates and to supervise the discarding method of the same
To perform periodic microbiological tests, as per Standard Operating Procedure (SOP)
To perform the Bacterial Endotoxin Test
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
Document contemporaneously all the activities performed
To test water samples for physicochemical tests, Biochemical and chemical tests and to document the activities
To maintain and update stock record of Limulus Amoebocyte Lysate (LAL) reagents
To qualify the personnel to enter in to the clean
To keep track of requirement 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 sample as per daily plan of work & in line with standard operating procedure
To perform the method validations as per the laid down protocol and to support qualification activities to support validation /qualifications
To prepare, maintain and reconcile Standard and house isolates / cultures for routine use
To maintain and update media stock record formats and in state of compliance
To intimate executive for any abnormalities in microbiological analysis. However, in the absence of executive, intimate the status of the same to Department Head
To support OOS, QMS, and other QMS elements towards timely closure
To perform the assigned activities other than or in addition to routine activities by supervisor, HOD or management team as and when organization needs