Microbiologist

A leading global manufacturer, marketer and distributor of health products and pharmaceuticals

Here is a place where every employee can influence change and make a difference. We are an employer where you have autonomy over your own work, can display personal initiative and make a difference.

Reporting to the QC Manager, the Senior Microbiologist ensures that the Microbiology laboratory provides the highest quality analytical support for manufacturing while ensuring compliance with protocols, cGMP and safety regulations in aseptic environmental monitoring and various microbial testing.

BSc degree in Microbiology
1-2 years industry experience in pharmacopoeia testing, sterilization validation and general pharmaceutical microbiology laboratory
Knowledge of, cGMP in pharmaceutical manufacturing
Knowledge of microbiology (industrial), environmental and utility monitoring and aseptic processing
Experience with sterility testing, endotoxin assays and validation, microbiological limits testing, knowledge of USP and EP/BP method/validation regulations, Microbiological identification methods

KEY DUTIES

• Performs and ensures that microbiology testing for raw materials and finished product is completed in a timely and accurate manner to meet product manufacturing requirements for manufacture and release.

• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and meets housekeeping and cleanliness standards.

• Reviews all documentation for accuracy and completeness and ensures that it’s in compliance with current GMPs/GLP, Good Documentation Practices, SOPs and company policies

• Specialize in the Aseptic manufacturing environmental monitoring (EM) and various microbial testing and performs testing, system suitability tests and EM and provides training and feedback to the Microbiologists as required.

• Specialize in various microbial testing and performs testing and training for Sterility test, BET, Bioburden, GPT, Microbial Assays and Identification and other related microbial testing

• Initiate, execute and participate as needed in the preparation of investigations relating to deviations in raw materials, finished products and environmental monitoring. Provides technical support in evaluating incidents and interventions during filling operations.

• Communicates to Management any corrective actions that need to be taken in response to excursions in controlled environmental conditions and makes recommendations.

• Schedules regular maintenance on equipment in coordination with lab work demands.

• Performs and participates in technical studies for research and development projects, and new product development projects as assigned or scheduled.

• Performs, executes and participate in microbiology validations and other projects and offers technical expertise for Microbiology investigations. Participates and assists validation in coordination of activities for media fills and personnel gown qualification.

• Responsible for Quarterly and Annual Environment monitoring trend reports, Microbial data deviation trend reports and water trend reports as assigned

• Revises laboratory Standard Operating Procedures as required.

• Ability to manage time efficiently and work without direct supervision.