09 Oct
|
Sun Pharmaceutical Industries
|
India
09 Oct
Sun Pharmaceutical Industries
India
Job Title:
Manager Microbiology
Business Unit:
Global Quality and Compliance
Job Grade
G10
Location :
Pithampur
Responsibilities
At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a cooperative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
• Coordinate equipment procurement, technical evaluation, installation and qualification.
• Participate in design review, risk assessment, constructability review and GMP review from a Microbiological perspective.
• Participate in DQ, FAT, SAT, IQ, OQ and PQ activities for systems impacting microbiological quality.
• Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves,
Incubators, Utilities
• Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
• Support qualification of: HVAC systems, Cleanrooms, Biosafety cabinets/LAFs, Autoclaves, Incubators, Utilities
• Prepare SOPs, Specifications, Standard Test procedures, QRM, Validation protocols & summary reports.
• Handling of Change Control, Deviation, CAPA, OOS/OOT.
• Perform/participate in contamination-control risk assessments & implementation of CCS.
• Support microbiological method verification/validation. Establish microbiological testing procedures based on applicable pharmacopoeia and regulatory requirements.
Microbial enumeration
Microbiological Assay
Sterility testing
Bacterial endotoxin testing
Bioburden testing
Water microbiology
Environmental monitoring
• Establish microbiological requirements for cleaning and disinfection programs & deve
📌 Manager Microbiology (India)
🏢 Sun Pharmaceutical Industries
📍 India