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 :
1. Participating during functional meetings that are needed to perform the activities in scope of this assignment.
2. Routinely working hours during the day shift at the manufacturing site ; 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).
3. Absences from the work station due to holiday, training or other reasons may not hinder the execution of this assignment.
4. Homework is allowed but may not hinder the execution of this assignment.
5. Working at days when the site is closed is allowed.
Scope of work for this assignment:
1. Coordinating supplier changes that are under the responsibility of the Pharm Tech Ops department.
a. Handling the changes in the Global Change Management system that are assigned to him/her by specific due dates that are determined based on the supplier implementation dates, available stock at supplier and lead times of change control process including execution of required implementation tasks.
b. Tracking the status of new and ongoing changes.
c. Coordinating the activities (planning, execution, finalization) together with internal (validation, production, planning, quality, laboratories, …) and external (global support functions, suppliers, …) parties.
d. Writing and executing protocols to support these changes.
e. Performing technical product evaluations of new or modified API/Raw Material/GMP supplies.
2. Performing periodic reviews of the different processes under the responsibility of the MSD Heist Pharm Tech Ops department to control the validated state.
3. Writing and updating procedures or work instructions within the scope of the activities.
4. Participating during internal and external audits for the projects he/she is working on.
Specific requirements (skills) or experience for the assignment?
- Pharmacist or Industrial/Chemical Engineer (Process techniques, Chemistry, Biology,..)
- Relevant experience in Pharmaceutical Processes, Validation and Project management
- The ability to implement theoretical technical knowledge into practice and to use this knowledge in a technical environment
- The ability to work on a project base
- Advanced knowledge of English (talking/writing/reading)
- Good technical writing skills
- Team player/Collaborative
- Motivated to work in a challenging environment
- Quality and scientific mindset
- Analytical thinking
- Balanced between pragmatic and detail-oriented
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Our projects are located at the most important (inter)national companies in various sectors, which means you will be introduced to the most modern techniques and the most diverse installations so that you can develop your knowledge and talent to the fullest.
In addition to an open-ended contract with an attractive, tailor-made salary, we offer numerous extra-legal benefits, including meal vouchers, a daily allowance, travel allowance or company car with fuel allowance, hospitalisation insurance,...
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