Description:
Scope of responsibilities and work:
After having processed the Standard Operating Procedures (=Safety & Quality) and required qualification work for the activities that are relevant for the scope of this assignment, hereby the scope of responsibilities :
* Participating during functional meetings that are needed to perform the activities in scope of this assignment.
* Routinely working hours during the day shift at the manufacturing site of Organon Heist o/d Berg; however some activities are also being performed at the production shop floor, thus working in an early/late shift is possible (exceptional during night/weekend shift).
* Absences from the work station due to holiday, training or other reasons may not hinder the execution of this assignment.
* Homework is allowed in exceptional circumstances but may not hinder the execution of this assignment.
* Working at days when the site is closed is allowed.
Scope of work for this assignment:
* Performing periodic reviews of cleaning processes at three production departments, called IPTs (Oral Solid Dosages; Liquids, Ointments & Creams; Sterile) to control the validated state.
* Coordinating and executing yearly re-qualification studies at any of the three IPTs (although in general practice the contractor shall focus on 1 IPT and be back-up for 1 other IPT)
* Providing support to cleaning projects (development & validation). Cleaning methods in scope are
a. Partswashers
b. Clean In Place
c. Manual
4. Coordinating the different activities together with validation, production and laboratories:
a. Making appointments with production and laboratories
b. Creation of LIMS requests
c. Execution of studies
d. Evaluation study data results
* Providing support to the monitoring program for potential cross contamination of active compounds by sampling non-product contact surfaces per approved protocols.
* Providing urgent and acute assistance to IPTs to sample dirty equipment or exceeding holding times
* Handling of deviations (administration, root cause analysis, ... ).
* Perform assessment of changes or act as a change owner
* Close audit gaps/observations
Specific requirements (skills) or experience for the assignment?
Diploma:
- Bachelor in Chemistry/Biology/Biomedical oriented studies or equivalent through experience
- Pharmacist or Industrial/Chemical/Bio Engineer (Process techniques, Chemistry, Biology,..)
Experience:
- Relevant experience in Pharmaceutical Processes, Validation and Project management
Technical skills:
* The ability to implement theoretical technical knowledge into practice and to use this knowledge in a technical environment
* Good technical writing skills
* Knowledge of English (talking/writing/reading)
Characteristics:
* Fluent/Communicative/Diplomatic
* Team player/Collaborative
* Motivated to work in a challenging environment
* Interest in work on the shopfloor
* Quality and scientific mindset
* Action-oriented
* Analytical thinking
* Flexible/Committed
* Autonomous