Requirements: English
Company: Planet Pharma
Region: Leiden , South Holland
We are seeking a highly skilled Quality Equipment Specialist to join our team, focusing on maintaining, calibrating, and qualifying equipment used in a cGMP-regulated environment. The ideal candidate will have hands-on experience with Prodigy, NC-202, and EndoSafe systems, ensuring compliance with industry standards and regulatory requirements.
Key Responsibilities
- Oversee the maintenance, calibration, and validation of critical laboratory equipment, including Prodigy, NC-202, and EndoSafe.
- Ensure all equipment operations adhere to cGMP regulations, company SOPs, and FDA/EMA guidelines.
- Conduct troubleshooting and performance qualification of equipment to optimize functionality and compliance.
- Develop and maintain documentation related to equipment validation, calibration, and operational procedures.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to support continuous improvement initiatives.
- Assist in audits and regulatory inspections, ensuring all quality-related equipment meets compliance requirements.
- Train personnel on proper equipment usage and best practices for maintaining a cGMP-compliant environment.
Qualifications
- Bachelor''s degree in Engineering, Life Sciences, or a related field (or equivalent experience).
- Minimum of X years experience working in a cGMP-regulated environment.
- Hands-on experience with Prodigy, NC-202, and EndoSafe instruments.
- Strong knowledge of FDA, EMA, and other relevant regulatory guidelines.
- Excellent troubleshooting and problem-solving skills.
- Ability to manage multiple priorities in a fast-paced setting.
- Strong documentation and communication skills.
Benefits
- Competitive salary and performance-based incentives.
- Health, dental, and vision insurance.
- Opportunities for professional development and career advancement.
- Collaborative and dynamic work environment.