QUALIFICATIONS

• B.Sc./M.Sc. in Microbiology
• Minimum 1-3 years of experience in Pharmaceutical microbiology laboratory environment preferred
• Strong Microbiology knowledge/experience preferred
• Ability to apply knowledge of microbiology, math, instrumentation and statistics to complete tasks
• Ability to work effectively in a team-based environment
• Proficiency with applicable software (LIMS, TrackWise)
• Strong organizational, analytical and multi-tasking ability
• Ability to troubleshoot and resolve issues
• Excellent written and verbal communication skills to support testing records, reports and investigations
• Thorough understanding of GMP’s

PHYSICAL REQUIREMENTS

Office based

JOB PURPOSE

The main responsibility of this position is to generate accurate results while following GMP requirements. Responsible for microbiological testing in microbiology laboratory, in accordance with established compendial and in-house testing methods, while under minimum supervision.

DUTIES AND RESPONSIBILITIES

• Microbiological testing as per USP <60>, <61> and <62> for RMs, In-process bulk, F/G and stability samples.
• Microbiological testing of purified water and city water.
• Environmental monitoring including active air, passive air, surfaces, compressed air and non-viable particulate counts.
• Perform microbial recovery studies for method validation.
• Perform Antimicrobial effectiveness studies and intrinsic antimicrobial testing.
• Antibiotic assays using cylinder plate method and turbidimetric analysis
• Media preparation, sterilization and QC testing of culture media for sterility and growth promotion tests
• Media preparation, sterilization and QC testing of culture media for sterility and growth promotion tests
• Operation and maintenance of microbiology laboratory equipment
• Document test results as per SOP and GMP
• Recognizes OOS or out of trend results and under the direction of the Supervisor/Manager assists in the completion of lab investigations
• Interpret data, communicate results and complete written reports
• Complete all GMP documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Conduct (participate or lead) routine laboratory and Non-Conformance Investigations
• Initiate and follow through with actions required to close Change Controls
• Evaluate methods and procedures and suggest improvements and changes as required
• Interpret data and complete written reports
• Routine maintenance of microbiology laboratories including daily, monthly and Quarterly cleaning and sanitization of the microbiology laboratory.
• Other duties as required

ADDITIONAL RESPONSIBILITY (ONLY APPLICABLE TO CUSTOMER FACING ROLES)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day