Operator B

About the Company

Prothya Biosolutions makes life-saving plasma medicines and is proud of it! Every day, Prothya colleagues are delighted to go the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible, fast-growing company with an interesting history?

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.

GMP roles and responsibilities

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

Qualifications

• 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

We Offer:

• Full-time employment (40h) 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.