Microbiology Section Head At Orchidia Pharmaceuticals
Providing leadership and direction to microbiology staff members through managing, planning and designing work instruction and schedules for performance of all jobs pertaining to the scope of microbiological control assessment and raw materials, finished products, utilities and manufacturing sites environment.
Ensure the development, implementation, and maintenance of quality control microbiology systems and activities.
Design work objectives to achieve microbiological control for raw materials and products.
Schedule, coordinate and monitor a wide variety of microbiological, biological tests which are performed in accordance with approved documents.
Participate in validation protocols of manufacturing sites and equipment.
Carry out microbial quality control tests and generate challenge test data.
Provide guidance to the microbiology team on the application of the internal and external regulatory requirements.
Conduct internal audits on department test methods and activities to confirm compliance and to identify improvement.
Design laboratory requirements with respect to facilities, equipment and instrumentation.
Maintain laboratory equipment in line with preventative maintenance schedules.
Develop and revise laboratory procedures in accordance with current testing guidelines and good manufacturing procedures.
Review and approve of documentation including SOP, logbook, validation protocols, reports and associated deviations.
Sample, inspect, analyze and record accurately raw materials, intermediates and final products.
Implement standards, methods and procedures for inspecting, testing, and evaluating the quality attributes of products, including the collection and administration of environmental monitoring data, testing, utilities and microbial identification.
Release products from testing once all criteria are met, as specified in the procedures and testing specifications
Implement, maintain and improve the management system.
Identify the deviations from the management system or from the procedures for performing laboratory activities.
Initiate actions to prevent or minimize deviations.
Report to lab management on the performance of the management system and any need for improvement ensuring the effectiveness of lab activities.
Review statement of conformity.
Train newly hired microbiologists, senior microbiologists and Supervisors properly on instruments and analysis ensuring their ability to perform all types of tasks assigned efficiently.
Ensures that instrumental quality control tests are performed according to methods of analysis.
Directing required additional investigation in quality control or production department as needed in case of OOS results.
Making decision as to the status of re-testing or re-sampling procedures.
Performing investigation in case the OOS result is not due to lab error.
Formulate and recommend technical training programs based on knowledge of identified training needs, company production processes or changes in products, procedures or services.
Follow up, maintain and ensure implementation of safety instructions and requirements in microbiology labs.
Follow up, maintain and ensure implementation of GLP, GMP and GDP rules.
Enforce subordinates' participation and implementation of the EHS management system.
SkillsBachelor’s degree in pharmaceutical science or science preferably in microbiology.
At least 10 years of experience in the pharmaceutical microbiological laboratory.
Able to carry out laboratory work in accordance with laboratory procedures.
Accurate generation, recording and presentation of test results.
Must have the ability to accurately execute protocols and prepare draft reports with supervision.
Ability to meet workloads and project deadlines.
Excellent English, verbal / written communication.
Excellent computer skills.
Pharmaceutical science or Science