Microbiology Supervisor - Quality Control /Pharmaceutical

A. ESSENTIAL DUTIES and RESPONSIBILITIES:

• Manage the Microbiology Laboratory ensuring that the equipment is functional (calibrated and well maintained) and suitable for analytical testing
• Manage workload and resources to ensure timely release of product. Manage the sampling and analysis of raw materials, intermediates, finished products, routine monitoring samples and others.
• Ensure that testing is carried out in compliance with specifications, Pharmacopoeia requirements and the cGMP and analyze the trend of the analytical results. Ensure the OOS investigation is conducted properly
• Ensure that Reference Standards as well as Standard Solutions are suitable and maintained according to the cGMP. Maintain and control the inventory of test material and consumables, including toxic reagents, ensuring that the budget is respected
• Release the Raw materials, Packaging materials and Semi-product(Imported) according to the test results
• Implement GAP analysis for global requirement and local authority standard and take CAPA actions
  Identify significant adverse quality trends by preparing and analyzing summary reports and key process indicators. Addresses quality control test results, microbial profiles of environmental areas, and customer complaints
• Keep close relationship and communication with other departments to ensure proper execution of the production plan. Lead and motivate the analysts for a continuous improvement of GMPs as well as HSE awareness. Be the Safety contact for the Laboratories
• Assist QC Section Head in planning and prioritizing resources allocation to meet test requirements. Responsible for training staff and overseeing and reviewing documentation
  Lead microbiological analysis of raw materials and finished products, environmental monitoring, water analysis, reviving of pathogenic microorganisms and different microbiological studies
• Ensure L1 Self Inspection procedures for area of responsibility are in place and in use
• Revise/update/draft Standard Operating Procedures (SOPs) governing the departmental activities
• Responsible for interdepartmental interactions to ensure customer service needs are satisfied and priorities understood
• Generate trend reports as they relate to quality testing
• Ensure sample submission for external testing
• Perform visual inspection of finished product, as needed
• Interact with internal departments, including Production, Facilities, Quality Assurance, Validation, Calibration, Materials, and Logistics as needed
• Ensure that an adequate supply of inventory levels is maintained
• Ensure that all documentation is neat and orderly and maintain all necessary documentation
• Conduct special studies as required and maintain inventory control
• Identify and implement issues and opportunities for improvements driven by continuous improvement inclination
• Supervise the collection and evaluation of incident report and change control data and ensures the necessary corrective actions are identified and implemented. Reviews and evaluates monthly and annual reports

Job Requirements

B. QUALIFICATIONS and EXPERIENCE:

• EDUCATION:Bachelor’s degree in the biological sciences or equivalent combination of education and experience
• EXPERIENCE :
  One to three years of progressive laboratory responsibility in support of pharmaceutical manufacturing or equivalent, related industrial or clinical experience. Supervisory experience preferred
  Must be knowledgeable of quality control testing methods, validation techniques and concepts of microbiology
  Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience in pharmaceutical applications
• IT LITERACY:Very good MS Office skills
• LANGUAGE:Good English proficiency both oral and writing

C. COMPETENCIES and BEHAVIORS:

• Good analytical and troubleshooting skills
• Must have excellent technical writing skills and high attention to detail
• Overcome conflicts with priorities for self and team; consult manager regarding major conflicts
• Have knowledge of environmental monitoring in clean rooms and classified environments
• Strong organizational skills in record keeping, data analysis and strong computer skills
• Trustworthy and unmatched integrity
• Flexible, having good communication skills & details oriented
• Excellent verbal and written communication skills are essential.