Support in additional cleaning validation activities

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 :

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 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).

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 in exceptional circumstances 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. Performing periodic reviews of cleaning processes at three production departments, called IPTs (Oral Solid Dosages; Liquids, Ointments & Creams; Sterile) to control the validated state.

2. 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)

3. 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

5. Providing support to the monitoring program for potential cross contamination of active compounds by sampling non-product contact surfaces per approved protocols.

6. Providing urgent and acute assistance to IPTs to sample dirty equipment or exceeding holding times

7. Handling of deviations (administration, root cause analysis, … ).

8. Perform assessment of changes or act as a change owner

9. 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