Senior Scientist Monitoring

Key Responsibilities :

As such, this position's scope of responsibilities are to:

• Establish and maintain quality systems associated with monitoring of utilities and environment.
• Act as contact in case of a project related to monitoring.
• Develop and maintain procedures, working instructions, protocols/report templates related to Environmental Monitoring and Clean Utilities qualifications.
• Drive the creation of Risk Assessments for definition of qualification and routine monitoring sampling points for CU and EM.
• Support CVQ team for protocols and reports establishment.
• Develop the monitoring and trending program including required procedure and monitoring/trending reports.
• Work collaboratively with all stakeholders to ensure that monitoring activities are planned and executed efficiently.
• Support the implementation of Laboratory Instrument Management System (LIMS)and other IT tool required for qualification and routine Monitoring.
• Support deviation resolution related to monitoring in cooperation with key partners (PRO, QMO, QCS).
• Ensure regulatory inspections by presenting qualification procedures, strategies and all related monitoring documents.
• Adheres to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management.
• Actively contributes to continuous quality improvement initiatives and deviation reporting and follow-up.
• Adheres to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
• Actively contributes to safety initiatives and issues as well as near miss reporting and follow-up.

Profile

• University degree in (Bachelor or Masters) in Life Sciences (Biology, Chemistry, etc.), Dipl. Ing. or M.Sc. or B.Sc. or equivalent.
• Language: Fluent in English, Fluency in German is a plus.
• Experience in the bio-pharmaceutical industry.
• Knowledge of cGMP including current knowledge of industry guidance documents and standards focusing on facility monitoring (Engineering and microbiology).
• Experience in Quality Systems like Change control, deviation including investigation, CAPA implementation.
• Intellectually curious and embraces Practical Process Improvement (PPI).

For further details or inquiries feel free to get in touch through email.