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Operator I or II
4 weken geleden
Job Title: Operator I or II
Contract Duration: 12 Months
Location: Haarlem, North Holland, Netherlands
Shift: Rotational (Morning/Evening/Night Shifts, including Weekends)
Operator I
As Operator I, you will be responsible for creating the dosage form for every batch of high-quality pharmaceutical products leaving our site. You will set up, operate, monitor, and improve equipment and processes used in the creation of our liquid-filled ampoules. Additionally, you will be responsible for loading and unloading our lyophilizers. Your actions will directly impact patients who rely on life-saving and life-strengthening medication every day.
Key Responsibilities:
- Set-up/start-up activities of filling machines in accordance with cleanroom SOPs and cGMP
- Ensure all equipment meets agreed standards – monitor equipment performance, troubleshoot faults, and adjust as necessary
- Provide assistance with basic equipment maintenance as required – follow instructions from the engineering team
- Take responsibility for adherence to health and safety procedures and good working practices to minimise accidents/incidents
- Perform operational tasks to improve the overall quality of the final product
- Ensure compliance with housing standards within your area(s) and in accordance with cGMP
- Play an active role in resolving process issues quickly and effectively, contributing to the achievement of the site's performance goals
- Take ownership of reporting non-conformities to the management team
- Correctly complete batch and associated production documentation in accordance with SOPs, ensuring compliance with cGMP
Operator II
As an Operator II in Complex Compounding, you will play a crucial role in the manufacturing of bulk pharmaceutical products. Your work will serve as the foundation for the fill-finish department, ensuring the creation of high-quality batches that contribute to life-saving and life-enhancing medications for patients. You will be involved in dispensing, compounding, and filtrating products in line with industry standards, contributing directly to patient care.
Key Responsibilities:
- Set up and start up equipment and processes in accordance with cleanroom Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP).
- Dispense, compound, and filter sterile pharmaceutical products, ensuring high standards of quality and safety.
- Assist in basic equipment maintenance as directed by the Engineering team.
- Adhere to Health and Safety protocols and best working practices to reduce accidents and ensure a safe work environment.
- Perform operational duties to ensure the final product meets quality standards.
- Maintain good housekeeping within your area in accordance with cGMP guidelines.
- Actively troubleshoot and resolve process issues promptly to meet site performance targets.
- Report any non-conformance issues to the management team for appropriate action.
- Accurately complete batch documentation and manufacturing records in line with SOPs and cGMP compliance.
Requirements:
- Recent graduate with a degree in a technical or scientific field, passionate about working in a company that improves the lives of patients
- Or experience working on a fill and finish line in a highly regulated environment such as food manufacturing, pharmaceuticals, medical devices, or a similar industry, without a degree background?
Additional Information:
This role requires flexibility with a shift schedule, including weekend work.
If you are interested in finding out more about this role or others, please contact Rachel McCorack at rmccormack@i-pharmconsulting.com or call at +44 (0) 20 7551 0719
