Microbiology Lab Supervisor
YOUR TASKS AND RESPONSIBILITIES
Develop, transfer and implement testing methods for materials, device components, packaging materials and drug products according to approved and validated test methods.
Validate and implement the testing of environmental monitoring samples, bioburden, monitoring and analysis (water, compressed air), endotoxin test, among others.
Responsible of writing and reviewing qualifications and validation protocols and reports in collaboration with other team members.
Responsible of local SOPs elaboration.
Support for delivering Bayer B certificates along the project delivery roadmap in required quality and aligned timeline corresponding to microbiology laboratory.
Support to create Quality Master Data for QM Module in SAP.
In charge of microbiology laboratory, reagents and consumable inventory for daily operation, possibility of regency.
Responsible of daily operation planning of the microbiology laboratory.
Responsible for the reliability of the daily analyses and results, data integrity, OOS and CAPA analysis, root cause investigation.
Directly supervise microbiology laboratory personnel in daily operation.
Support the calibration and maintenance programs for the microbiology laboratory equipment.
Laboratory metrics elaboration.
Supports hire process, performs training of laboratory technicians (laboratory work).
WHO YOU ARE
University degree in Microbiology.
Excellent English language skills.
5 years of experience in microbiology laboratories.
2 years of experience with validation of analytical methods.
2 years of experience supervising.
Statistical Techniques Knowledge.
Knowledge of QMS systems and subsystems.
Process Validation Knowledge.
Knowledge of laboratory systems.
Knowledge of environmental monitoring, critical systems monitoring and pharmaceutical / medical devices culture methods.
Knowledge of current Good Manufacturing Practices (cGMP’s).
Knowledge of ISO system (9001, 13485, 14644, 17025 is desirable)
Application Period : 07 / 06 / 2021 - 21 / 06 / 2021 Reference Code : 417309 Division : Pharmaceuticals