Operator B - Cofact

1. Performing Production Operations

Performs production operations on assigned processes using SOPs and applicable regulations;

Performs arithmetic calculations for dilutions and interprets results;

Prepares equipment, materials and work areas for production activities;

Documents all work performed in logs and batch records;

Administers raw materials and consumables in the information system.

Deliverable:

Properly prepared and executed pharmaceutical manufacturing operations in compliance with GMP requirements, including accurate documentation and escalation of deviations where applicable.

2. Recording, Administering and Reporting Deviations

Identifies, documents and reports deviations from established procedures to the Senior Operator or Supervisor;

Performs administrative processing of rejected materials;

Supports investigations and corrective actions where required.

Deliverable:

Timely identification and reporting of deviations and accurate administration of rejected materials.

3. Performing Quality-Related Activities

Performs checks on products, processes and materials, including sampling and inspections;

Delivers samples to designated locations for testing;

Performs routine validation and calibration activities in accordance with procedures;

Reviews and interprets results;

Reports deviations to the Supervisor;

Records quality data in applicable systems;

Supports the maintenance and revision of SOPs and quality documentation.

Deliverable:

Quality controls and quality assurance activities completed in accordance with GMP standards, ensuring product quality and patient safety.

4. Performing Operational Support Activities

In addition to the Cofact process activities, the Cofact Team is responsible for a variety of general support activities, including:

Weighing of raw materials;

Performing filter integrity tests;

Preparation of buffers and process solutions;

Cleaning and sterilization of small equipment parts;

Calibration of equipment, including balances, pH meters and conductivity meters;

Receipt and handling of incoming materials;

Organization and maintenance of warehouse and storage areas.

Deliverable:

Efficient execution of support activities ensuring continuity, compliance and operational readiness of the production department.

5. Workplace and Equipment Management

Cleans and sanitizes equipment and materials;

Performs minor technical maintenance and troubleshooting;

Reports equipment malfunctions and coordinates with technical specialists when required;

Maintains inventory levels and ensures timely replenishment of materials.

Deliverable:

A safe, clean and GMP-compliant workplace with sufficient materials and operational equipment.

6. Other Duties

Performs all other duties incidental to the position.

MBO level 4 or Bachelor's degree in a relevant discipline, or equivalent experience;

Experience in a GMP-controlled pharmaceutical, biotech or life sciences environment;

Knowledge of pharmaceutical manufacturing processes and GMP requirements;

Strong attention to detail and commitment to quality;

Proactive, structured and capable of working independently as well as in a team;

Fluent in Dutch and English, both written and spoken;

Willing to work in a 16x5 operational schedule.

Full-time employment (40 hours per week) within the dedicated Cofact Team;

Competitive salary in accordance with Prothya compensation policies;

8.33% end-of-year bonus and 8.33% holiday allowance;

Personal training budget of €2,100 every three years for professional development;

Travel allowance from the first kilometre;

Excellent accessibility by public transport and on-site parking facilities;

Pension scheme through Zorg & Welzijn;

A dynamic, safe and challenging working environment where you contribute directly to life-saving medicines for patients worldwide.