Quality Engineering Specialist

Prothya Biosolutions

Amsterdam

Hybrid

EUR 50,000 - 70,000

Full time

14 days+

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Benefits offered by this job

Competitive salary

16.66% budget for holiday allowance and bonuses

Flexible working hours

Personal training budget of €2,100 every 3 years

Travel expenses contribution

Good public transport accessibility

Job summary

A pharmaceutical company in Amsterdam is seeking a QC Engineer Specialist to support the introduction and validation of analytical methods. The ideal candidate will have a Master’s degree in analytical chemistry and expertise in chromatography, with a commitment to quality and collaboration. This full-time role offers competitive salary and benefits including a personal training budget and flexible work hours.

Qualifications

At least 3 years of experience in a GMP environment.
Familiar with international guidelines and pharmacopoeia testing.
Demonstrate excellent written and oral communication skills in English.

Responsibilities

Develop and implement methods in the QC lab following AQbD principles.
Write and review various GMP documents including reports and assessments.
Provide support for QC-operations troubleshooting and investigations.

Skills

Expertise with chromatography (HPLC, GC, IC)

Quality mindset

Strong communication and collaboration skills

Project management experience

Stress-resistant and proactive mentality

Education

Masters degree in analytical chemistry or relevant subject

Job description

Direct message the job poster from Prothya Biosolutions

Lead Talent Acquisition at Prothya Biosolutions - currently out of office till August 11th.

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.

Seniority level

Seniority level
Mid-Senior level

Employment type

Employment type
Full-time

Job function

Industries
Pharmaceutical Manufacturing

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