Requirements: English
Company: Prothya Biosolutions
Region: North Brabant
Are you an experienced QC Engineer Specialist looking for a new challenge? At QC Support, part of Prothya Biosolutions B.V., we are seeking an enthusiastic team player to support our group in the introduction and validation of multiple analytical methods.
About QC Support Global:
- Our team supports the QC-Operations lab team with method validation, verification, transfer, troubleshooting and specification setting. We coordinate QC topics in global projects across the sites in Amsterdam and Brussels.
Key responsibilities:
- Method development and validation/verification: Develop and implement methods in the QC lab following Analytical Quality by Design (AQbD ) principles and international guidelines.
- Validation Documentation: Write and review various essential GMP documents including reports, risk assessments and periodic reviews.
- Quality Lab Support: Providing support for QC-operations troubleshooting and investigations following quality events, deviations and CAPAs.
- Continuous improvement: Maintain the quality level of multiple analytical methods and improve processes and collaborations between teams.
Your skills and experience:
- Masters degree in analytical chemistry or relevant subject, with at least 3 years of experience in a GMP environment.
- Expertise with chromatography (HPLC, GC, IC) and other analytical techniques. Knowledge of general pharmacopoeia testing and raw material specification setting is a plus.
- Familiarity with international guidelines, pharmaceutical QC testing per Pharmacopoeia monographs (Ph. Eur and USP) and method verification.
- Experience in with method development and validation following AQbD, and following ICH Q2 and Q14 guidelines.
- Quality mindset and project management experience is preferred.
- Stress-resistant, enthusiastic and proactive mentality to get things done.
- Strong communication and collaboration skills with different stakeholders, a real team player.
- Demonstrate excellent written and oral communication skills in English, with proficiency in Dutch being a plus.
Join us and make a difference! Apply now to grow your career and contribute to our innovative team.
What We Offer:
- A full-time position with a competitive salary.
- A budget of 16.66% (holiday allowance and year-end bonus) of your gross salary, which can be used monthly.
- Flexible working hours, subject to agreement.
- Personal training budget of 2,100 every 3 years.
- Contribution to travel expenses from the first kilometer.
- Good accessibility by public transport, with private parking options available.
- Pension plan with Zorg & Welzijn.