We are looking for a
Senior Scientist Monitoring
In this position, you will be responsible to develop and maintain the overall Environmental Monitoring program. This position will also be responsible for the qualification strategy, documents, sampling plans, procedures, protocols/reports, monitoring program, trend evaluation and requalification as required.
This role will plays as a Subject Matter Expert for Clean Utilities and Environmental Monitoring aspects and will play a key role during health authority inspections.
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.