GMP Roles and Responsibilities
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.
Qualifications
- 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.
We Offer
- 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.
