Analyst QC | Brussels | Day shift


Purpose of the Job

As a Quality Control Analyst, you will play a key role in performing quality control analyses of raw materials, as well as associated biochemical testing, in accordance with established specifications and validated analytical methods. You will be responsible for executing routine analyses and more complex analytical investigations, interpreting results, and documenting the data generated.

You will also provide technical support and contribute to the training of less experienced analysts to ensure a consistent application of methods and laboratory best practices.

All activities will be carried out in strict compliance with Good Manufacturing Practices (GMP) requirements, safety regulations, internal procedures, and data integrity standards.

Your primary mission will be to ensure the reliability, accuracy, and timely availability of analytical results, while guaranteeing the compliance of raw materials with quality specifications and contributing to the continuous improvement of analytical and documentation processes.

Accountabilities

Key Activities

1. Work Planning and Organization

In collaboration with the Coordinator, Team Leader, and Supervisor, you review instructions, guidelines, and priorities. Together, you discuss the tasks to be performed to ensure optimal work organization. You carry out the necessary preparations to maintain a clear and structured overview of the activities to be completed.

In this context, your responsibilities include:

  • Participating in planning activities and priority setting in collaboration with the management team (Coordinator, Team Leader, Supervisor).

2. Quality Control Testing

You perform quality control analyses on raw materials, intermediates, and production-related samples in accordance with current specifications and approved analytical methods.

Your responsibilities include:

  • Receiving samples in SAP, registering them, and allocating them according to the required storage conditions.
  • Collecting water, clean steam, and compressed air samples in accordance with the environmental and utilities monitoring plan.
  • Preparing samples, including the dissolution of intermediates and raw materials, as well as preparing the dilutions and aliquots required for testing.
  • Performing scheduled biochemical and physicochemical analyses in accordance with applicable procedures, analytical methods, and specifications.
  • Verifying, interpreting, and conducting first-level reviews of analytical results, and comparing them against predefined acceptance criteria.
  • Participating in analytical investigations related to Out-of-Specification (OOS) results, Out-of-Trend (OOT) results, deviations, or other anomalies, in collaboration with the relevant teams.
  • Accurately documenting analytical activities and ensuring data traceability in compliance with GMP requirements and ALCOA+ data integrity principles.
  • Monitoring expiry dates of reagents, solutions, reference standards, and laboratory consumables, and managing laboratory inventories.
  • Writing and/or executing qualification, validation, and verification protocols for analytical methods, equipment, and control standards, as well as preparing the associated reports.


3. Technical Support and Laboratory Expertise

You provide technical support and contribute to the efficient operation of the laboratory by leveraging your expertise to support your team.

Your responsibilities include:

  • Drawing on your in-depth knowledge of analytical methods, raw materials, and manufacturing processes to assess the impact of anomalies or atypical results and contribute to analytical investigations.
  • Sharing your expertise with colleagues by supporting them in troubleshooting technical issues and ensuring the correct application of analytical methods.
  • Participating in the training and technical support of less experienced analysts to ensure consistent application of procedures and laboratory best practices.
  • Supporting internal and external audits, as well as regulatory inspections, by preparing the required documentation, ensuring the availability of laboratory records, and responding to requests within your area of expertise.

4. Documentation and Data Integrity

You ensure complete, accurate, and compliant documentation in accordance with Good Manufacturing Practices (GMP) and data integrity principles throughout the execution of your activities.

In this role, you are responsible for:

  • Preparing, completing, reviewing, and submitting all required analytical documentation (worksheets, logbooks, forms, analytical records, and electronic records) in accordance with applicable procedures.
  • Maintaining real-time documentation that is legible, complete, accurate, and fully traceable, in compliance with GMP requirements and ALCOA+ principles.
  • Keeping reagent logs and laboratory activity records up to date to ensure full traceability of laboratory operations.
  • Verifying the accuracy and consistency of recorded data before submission or review.
  • Reporting and documenting any documentation-related anomalies or deviations in accordance with applicable quality procedures.

5. Quality, Safety, and Compliance

You are responsible for ensuring the quality, safety, and compliance of all activities performed, in accordance with applicable regulations and requirements related to Good Manufacturing Practices (GMP), Safety, Health, and Environment (SHE).

In this context, you are committed to:

  • Maintaining the qualifications, training, and certifications required to perform your activities safely, competently, and in compliance with applicable regulations.
  • Applying internal procedures as well as legal and regulatory requirements related to quality, safety, hygiene, and environmental protection.
  • Using laboratory equipment and materials in accordance with established procedures and promptly reporting any situation that may pose a risk to quality, safety, or the environment.
  • Actively contributing to risk prevention, maintaining a safe working environment, and complying with company policies related to health, safety, and environmental protection.
  • Participating in the continuous improvement of quality, safety, and environmental practices by proposing improvement actions and ensuring compliance with applicable procedures.

6. Continuous Improvement

You actively contribute to the continuous improvement of laboratory activities by identifying optimization opportunities, strengthening process robustness, and supporting the evolution of analytical practices.

In this capacity, you:

  • Proactively identify opportunities to improve work methods, analytical processes, and laboratory organization.
  • Propose, implement, and monitor improvement actions aimed at enhancing the efficiency, quality, compliance, and reliability of departmental activities.
  • Report deviations, incidents, or risk situations and participate in investigations and the implementation of corrective and preventive actions (CAPAs) to prevent recurrence.
  • Contribute to the drafting, review, and continuous improvement of quality documentation (SOPs, work instructions, specifications, protocols, forms, and laboratory documents) to ensure regulatory compliance and alignment with operational practices.
  • Act as a technical subject matter expert for the methods or equipment under your responsibility and contribute to their continuous improvement by participating in qualifications, validations, method transfers, and analytical optimization activities, as required.
  • Participate in improvement, qualification, validation, or optimization projects related to analytical activities and laboratory processes.

Education, Experience, and Skills

Education

  • Bachelor’s degree in (Bio)Chemistry, (Micro)Biology, Industrial Pharmacy, Biotechnology, or equivalent relevant experience.

Experience

  • Minimum of 3 years of experience in a similar role within the pharmaceutical industry.

Skills

  • Proficiency in common IT tools, particularly the Microsoft Office Suite; knowledge of quality systems such as SAP and/or MasterControl is considered an asset.
  • Good command of technical English and professional proficiency in either French or Dutch.
  • Strong attention to detail, a methodical approach, and a quality-focused mindset, with the ability to work independently while adhering to established procedures.
  • Ability to manage priorities, organize work efficiently, and meet deadlines in an environment where multiple tasks may be performed simultaneously.
  • Strong communication and collaboration skills, enabling effective interaction with various stakeholders to achieve shared departmental objectives.
  • Demonstrated punctuality, reliability, and a strong sense of accountability.
  • Ability to identify situations that may pose a safety or quality risk, document incidents and near misses, and contribute to the implementation of appropriate corrective actions.
  • Commitment to promptly escalating quality issues, deviations, or anomalies to management in accordance with established procedures.
  • Strong analytical and problem-solving skills, along with close attention to detail, essential for performing analytical activities in a GMP-regulated environment.
  • Following an initial training and onboarding period, you may be required to participate in on-call duties or weekend activities (up to two weekends per month), with compensatory time off and remuneration provided in accordance with applicable company policies.

Our Company 

Prothya Biosolutions makes life-saving plasma medicines and is proud of that! Every day, Prothya colleagues take the extra mile to improve the health of millions of patients worldwide. Are you looking for a position at a flexible and fast-growing company with an exciting history? At Prothya you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! 


We offer


Prothya Biosolutions Belgium is part of an international biopharmaceutical group which offers long-term career perspectives and invests actively in on-the-job training.


In return for your performance, you shall receive a competitive salary, group and health insurance, meal vouchers, and eco-cheques, as well as a Flex Reward Plan. The Flex Reward Plan is a flexible compensation system through which employees can create a budget from their current salary components. Thanks to this plan, they can enjoy, on a voluntary basis and according to their personal choice, a series of benefits that Prothya Biosolutions Belgium offers once a year.


We also offer an attractive holiday system exceeding the legal holidays.


Furthermore, we value mutual respect and diversity is our strength.


At Prothya, you can count on an attractive, safe and challenging working environment where everyone gets the chance to show the best of themselves. There is also plenty of room to grow, innovate and learn! 


Are you moving along? Then apply now!



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