Microbiologist

Roles & Responsibilities:
• Ensure implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards
• Perform periodic microbiological testing as per approved SOPs
• Conduct Bacterial Endotoxin Test (BET) using LAL reagents and maintain related stock records
• Perform pre-sterile bio-burden testing for materials and RM/PM bio-burden analysis
• Collect and conduct sterility testing of samples as per protocol
• Perform microbiological analysis of stability samples as per daily work plan
• Conduct physicochemical, biochemical, and chemical testing of water samples
• Prepare, qualify, and perform Growth Promotion Tests for culture media
• Perform gram staining and microbial identification (e.g., BBL crystal system)
• Support method validation and qualification activities
• Maintain and reconcile standard and in-house isolates/cultures
• Document all activities contemporaneously in compliance with data integrity requirements
• Coordinate with Technical department for equipment abnormalities impacting microbiological quality
• Support OOS investigations, QMS activities, and timely closure of quality events
• Qualify personnel for cleanroom entry as per microbiological standards
• Monitor stock requirements and provide monthly procurement needs
• Report abnormalities to Executive / Department Head as required
• Perform additional tasks assigned by Supervisor, HOD, or Management

Qualification:
• B.Sc / M.Sc in Microbiology or related Life Sciences discipline
• Pharmacy graduates with microbiology exposure may be considered
• Bachelor of Pharmacy (B.Pharm), Master of Pharmacy (M.Pharm)

Experience:
• Relevant experience in microbiology laboratory within pharmaceutical manufacturing environment preferred

Skills:
• Strong knowledge of cGMP and microbiological laboratory practices
• Hands-on experience in sterility testing, bio-burden testing, and endotoxin analysis
• Understanding of QMS, OOS, and validation processes
• Good documentation and data integrity compliance (ALCOA+) awareness
• Attention to detail and analytical problem-solving skills
• Ability to work in cleanroom and controlled environments

About the Organization:
Baxter is a global healthcare company committed to its mission to Save and Sustain Lives. With a legacy dating back to 1931, Baxter focuses on advancing healthcare delivery through innovation, quality, and operational excellence.