QC Officer - Quality Control Operations

Prothya Biosolutions; Amsterdam; On-site; EUR 47,000 - 67,000; Full time

Benefits offered by this job

40 h work week

Holiday allowance 8.33%

13th month pay

30 holiday days

Training budget €2,100 every 3 years

Travel expense contribution

Public transport access

Pension plan Zorg & Welzijn

Job summary

Prothya Biosolutions is seeking a Quality Control Officer to uphold GMP standards and drive investigations into deviations and OOS results. You will lead CAPA activities and work closely with QC labs and cross-functional teams to ensure compliant product releases.

This role emphasizes on-site collaboration, rigorous documentation, and strong communication in English and Dutch. A Master or Bachelor in analytical science is required, with 5+ years in QC environments within pharma/biotech.

Qualifications

• Bachelor or Master degree in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• 5+ years work experience within analytical chemistry and/or microbiology and/or incoming goods in a QC environment in the pharmaceutical or biotech industry.
• Experience in deviation management, investigations, root cause analysis and corrective actions.
• Ability to lead investigations and manage CAPA processes.
• Strong understanding of GMP and regulatory requirements.
• Experience with measuring-equipment qualification and maintenance.
• Analytical thinking and problem-solving abilities.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Articulate written and oral communication, able to deliver messages clearly.
• Proficiency in documentation practices and attention to detail.
• Ability to work under stress and prioritize tasks.
• Team player mindset for supporting colleagues.
• Strong grasp of English and Dutch (conversational).
• Ability to work fully on-site.

Responsibilities

• Demonstrates independent understanding and application of GMP fundamentals and data integrity.
• Perform investigations on non-conformances, deviations, and OOS results with root cause analysis.
• Conduct routine audits to ensure GMP compliance.
• Support and guide laboratory personnel in QC practices and regulatory requirements.
• Collaborate with cross-functional teams to facilitate product release and resolve quality issues.
• Assist in identifying and implementing improvements.

Skills

GMP knowledge

Root cause analysis

CAPA processes

Analytical thinking

Communication skills

Documentation practices

Team player

Dutch language

English language

On-site work

Education

Bachelor or Master in Analytical Chemistry, Pharmaceutical Sciences, or related field

Tools

Measuring equipment qualification

Laboratory maintenance

Job description

As a Quality Control (QC) Officer in our Quality Control Operations, you'll play a pivotal role in maintaining the highest standards of product quality and compliance. Your expertise in Good Manufacturing Practice (GMP) and quality management will guide our teams, ensuring that every product meets our rigorous standards. You'll be actively involved in identifying and resolving quality issues, performing inspections, and driving continuous improvement initiatives. If you're detail-oriented and enjoy collaborative problem-solving in a complex organisation. As such, this role offers both challenge and fulfilment.

About the Role

As a QC Officer in our Quality Control Operations, you'll play a pivotal role in maintaining the highest standards of product quality and compliance. You will act as an SME in performing investigations, constantly looking for information: who, what, where, why and defining solutions to prevent from happening again. This role involves collaboration with different people within the organization and is therefore important to be a good listener, helper, thinker and sometimes persuasive to get colleagues on board with the necessary changes. It is also important to learn to deal with setbacks, as there can be times when decisions are made that you do not fully support. If you're detail-oriented and enjoy collaborative problem-solving in a complex organisation. As such, this role offers both challenge and fulfilment.

Responsibilities:

• Demonstrates independent understanding and application of GMP fundamentals, including but not limited to: Good manufacturing practices, good documentation practice and data integrity.
• Perform investigations on non-conformances, deviations, and out-of-specification (OOS) results. Is acknowledgeable of root cause analysis tools.
• Conduct routine audits to ensure compliance with GMP and quality standards.
• Support and guide laboratory personnel in quality control practices and regulatory requirements.
• Collaborate with cross-functional teams to facilitate product release and resolve quality issues.
• Assist in identifying and implementing improvements

Requirements:

Your profile:

• Bachelor or Master degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• >5 years work experience within analytical chemistry and/or microbiology and/or incoming goods in a QC environment in the pharmaceutical or biotech industry.
• Experience in deviation management, on how to perform investigations, root cause analysis and define corrective and preventive actions.
• Ability to lead investigations and manage CAPA processes.
• Strong understanding of GMP and regulatory requirements.
• Experience with measuring-equipment, qualification, and maintenance.
• Analytical thinking and problem-solving abilities.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Articulate written and oral communication, able to deliver effectively a message
• Proficiency in documentation practices and attention to detail.
• Ability to work under stress, while being able to prioritize tasks.
• A true team player, you want your colleagues to be happy and successful too
• Strong grasp of English, both verbal and written. Conversational level of Dutch.
• Ability to work fully on-site.

What We Offer:

• Full-time employment (40h) with flexible working hours in consultation. Working part-time (32h or 36h) is possible as well
• Salary between € 4.179,77 and € 6.008,42 euro gross per month based on full-time employment.
• 8.33% holiday allowance and 8.33% end-of-year payment (13th month).
• 30 holiday days.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.