Job Description
The Microbiology Analyst role exists to ensure that microbiological testing of materials, products, facilities, equipment, systems and processes is done accurately, effectively and complies with External Regulatory requirements in support of the supply chain.
Key Roles
Fundamentals (Safety, Quality, people and Process)
Perform material and finished product microbiological testing to ensure quality of the final product before release according to SOPs.
Accurately, timely and according to Good Documentation Practices document results in the microbiology lab results forms and Master Batch Records.
Sample and perform microbiological analysis of water to ensure microbiological control of the water systems.
Maintain and review microbiological SOPs, reports and forms. Keep all documents under neat and safe conditions.
Prepare, control through inventory and Growth Promotion Tests culture media in the lab.
Prepare, control and standardize reagent usage in the lab.
Monitor stock levels of culture media, reagents, glassware and other lab consumables to avoid stock outs.
Participate in environmental monitoring through swab, ambient air and compressed air testing and trending of data.
Carry out testing of detergents and disinfectants.
Maintain reference cultures.
Carry out Preservative Efficacy Tests according to the stability programme.
Report to the Microbiologist any results deviating from the set specifications or limits and participate in laboratory investigations.
Maintain safety and 5S principles within the microbiology lab environment.
Carry out calibration checks and routine maintenance on all microbiology lab equipment and instruments.
Train/coach new personnel, cleaning staff and interns in the microbiology lab.
Update informational Microbiology lab boards.
Innovate the Business
Support laboratory KPI targets.
Carry out self audits in the laboratory as per the set schedules to ensure compliance to in-house specifications, standards, and good manufacturing practices; and support in action plans.
Respond flexibly to changing demands and operating conditions.
Provide support to lab projects, site projects, improvements and GPS initiatives.
Strategic Alignment & Sustainability
Support in responding flexibly to changing demands and operating conditions including changes within the regulatory environment.
Use laboratory consumables effectively in support of the performance of budgets.
Active engagement with staff on the production floor to support microbial contamination control strategies.
Active engagement in problem solving and performance management in the lab through microbiology lab and/or quality Tier 1 meetings.
Open and receptive to coaching.
Support EHS culture.
Risk Management
Support implementation and execution of audit programmes on site (both L1 and L2).
Work with Cross-functional teams to deliver the Zero Waste, Zero Accident and Zero Quality ambition.
Engage cross functional teams to ensure there is a smooth flow of product to the market.
Ensure lab activities are carried out in compliance with ethical standards, GMP and relevant current standards.
Experience and skills
Attention to details is required especially in result observations, interpretation, recording and release of products and materials.
Resilience as an individual and able to drive the same through open and honest engagements.
Independent thinking in supporting investigations or during problem solving.
Ability to influence peers in achieving shared goals.
Open to change in support of initiatives and strategies.
High Performance Behaviours:
Enable and Drive Change.
Continuous Improvement.
Customer Focus.
Developing People.
Sense of Urgency
Flexible Thinking
Building Relationships
Strong customer focus
Operate with a strong sense of integrity, ethics, responsibility and commitment
Good verbal and written communication skills
Result-oriented
Strong team player
Problem solving skills
Significant QA experience within the Pharmaceutical industry including experience within a Microbiology Lab.
Learning agility
Qualification/ Experience:
Diploma or degree in Microbiology, Food Science, Biomedical lab sciences or related sciences.
Minimum 2 year experience in a similar role with proven track record in achieving results.
Manufacturing experience/background preferable pharmaceuticals and/ or FMCH organizations.
Good understanding of GMP.
