Providing analytical experts for any project, troubleshooting, investigation on analytical methods and lab technologies.
Coordinate analytical testing on projects (validation/transfer), ensuring adherence to the committed scheduled plans
Performing his/her tasks in accordance with cGMP and HSE requirements, and with the associated instructions, procedures, records related to these tasks
Recording all expected raw data, calculations, information, related to his/her tasks, to comply with cGMP and Data integrity requirements
Writing/reviewing protocols and reports related to analytical validation/transfers and qualification activities
Writing/reviewing and maintaining accurate analytical methods procedures
Informing his/her manager of any quality or HSE event (deviations or OOx) in a timely manner to ensure investigation and impact assessment are performed appropriately
Participating actively to any investigation, where he/she is involved, to ensure investigations and impact assessment are performed appropriately
Performing periodically trend analysis on method performance to determine the need to revalidate, optimize or replace the method
Ensuring that his/her lab/facilities, lab instruments, are kept in a quality and safety status to ensure that they can be used appropriately
Supporting QC teams during internal, external audits and inspections
Qualifications
Higher Level degree in science or equivalent technical discipline
3years + experience within Pharmaceutical Development, Analytical and/or Manufacturing department
Experience in quality control within the pharmaceutical industry, including knowledge of Good Manufacturing Practices (GMP) and regulatory requirements.
Ability to analyse complex data and laboratory results to make informed decisions and identify areas for improvement.
Keen attention to detail to ensure accuracy in testing, reporting, and compliance with regulatory requirements.
Proficiency in identifying issues and implementing effective solutions to resolve quality control problems.