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Proces Operator B - Formulation
Prothya Biosolutions Netherlands B.V.
About the role
As Operator B you are carrying out pharmaceutical production activities under quality conditions with blood plasma and (intermediate) products manufactured from it, including a number of production operations that are different in nature, often recurring daily on several production lines.
What you'll do
1. Performing production operations
- Performs production operations on some processes using SOPs and regulations;
- Performs arithmetic operations for the purpose of dilutions and interprets their results;
- Provides preparations for the production process;
- Accounts for the performance of all work in logs and protocols;
- Administers raw and auxiliary materials in the information system.
Deliverable:
Properly prepared and carried out as prescribed, controlled and responsible pharmaceutical manufacturing operations, even if a deviation occurred during preparation.
2. Recording, administering and reporting deviations in the production process
- Identifies, records and reports deviations in prescribed operating procedures to the senior operator or supervisor;
- Performs administrative processing of rejected materials.
Deliverable:
Discrepancies found, recorded and passed on as directed; records of rejected goods in order
3. Performing work for the purpose of quality
- Performs checks on products, processes and (auxiliary) materials, including by sampling and inspection;
- Delivers samples for inspection at the designated location;
- Routinely performs validation and calibration work for quality control purposes in accordance with regulations;
- Reviews and interprets results;
- Reports deviations to supervisor;
- Records quality control results in the information system;
- Writes standard validation and calibration reports and modifies SOPs as needed.
Deliverable:
Performed quality controls such that quality and safety of the product within the relevant production step is ensured. Contributed to quality assurance through up-to-date quality documents and validated calibrated equipment
4. Performing workplace management
- Cleans used equipment and materials;
- performs minor (technical) maintenance on equipment, fixes malfunctions of a simple nature, reports malfunctions to the supervisor, has contact with internal or external experts/technicians when necessary and supervises them in handling malfunctions;
- Maintains inventory and ensures timely replenishment.
Deliverable:
Hygienically maintained workplace; stock maintained such that work can continue
5. Performing all other duties incidental to the duties of the position
What you'll bring
MBO / Bachelor education in a relevant discipline or equivalent level gained through experience
1 year experience in a similar function within a GMP controlled environment
Strong pharmaceutical packaging process experience
Detail-oriented, structured, proactive, and a strong team player
Fluent in Dutch and English
Willing to work in shifts
What's on offer
Full-time employment (36h) with a competitive salary.
Total shift allowance following AVR.
8.33% end-of-year bonus and 8.33% holiday allowance.
A personal training budget of €2,100 every three years to foster professional growth and development.
Contribution to travel expenses from the first kilometer.
Excellent accessibility by public transport and private parking available.
A pension plan with Zorg & Welzijn, providing security for your future.
A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.