Engineer QA Operational | Brussels

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Neder-Over-Heembeek; On-site; EUR 65,000 - 85,000; Full time

Job summary

Prothya Biosolutions BE is seeking a Quality Engineer to ensure GMP-compliant operations and quality assurance across all levels. You will review batch records, manage deviations and CAPAs, and support risk analyses, qualification and validation projects.

The role requires a Master’s degree in a related field with at least 3 years in pharma/biotech, English fluency, and French or Dutch language skills. MS Office proficiency and knowledge of SAP/MasterControl are assets.

Qualifications

• Master’s degree in Chemistry/Industrial Pharmacy or related field.
• At least 3 years of experience in pharma, medical device or biotech.
• Knowledge of quality systems and GMP/SOPs is a plus.
• Proficient with MS Office; SAP/MasterControl is a plus.
• Fluency in English; French or Dutch is essential; knowledge of the other language is a plus.
• Analytical, problem solver, result-oriented, decisive.
• Pragmatic, customer-oriented, persuasive, communicative.
• Stress resistant, flexible, and willing to provide telephone support outside office hours.

Responsibilities

• Review batch records and prepare documentation for release.
• Assess events/deviations, OOS/OOL and complaints (to vendor).
• Monitor procedures, protocols and reports; correct and authorize them.
• Perform GxP checks on the shop floor and support improvements.
• Participate in risk analyses, qualification and validation projects.
• Contribute to training and informing employees about quality and regulations.
• Report to supervisor on batch record review and quality system records.

Skills

Quality assurance

Analytical thinking

Problem solving

Communication

Stress resistance

Flexibility

Education

Master’s degree in related field

Tools

SAP

MasterControl

Job description

Objectives:

As Quality Engineer, you are responsible for guaranteeing quality by following up and ensuring that all operations at all levels are done according to the applied GMP quality systems at Prothya Biosolutions BE. In this way, you help ensure that the quality of the pharmaceutical products from Prothya Biosolutions BE fulfils the European and American GMP guidelines.

Key responsibilities and result areas:

1. You are responsible for guaranteeing quality by following up and ensuring that processes and activities are carried out according to the applicable cGMP quality standards:

• You perform review of batch records and prepare the documentation for the release department.
• You assess events/deviations, OOS/OOL and complaints (to vendor).
• You monitor written documents such as procedures, protocols and reports concerning quality systems from other departments.
• You take care of the correction and authorization of those procedures, protocols and reports.
• You perform GxP-checks on the shopfloor in different departments and support people to improve.

2. You participate in different projects related to risk analyses, qualification and validation:

• You are responsible for performing risk analyses and determining corrective and preventive measures (CAPAs).
• You participate in or supervise quality-related projects.

3. You are responsible for informing, making aware and training Prothya Biosolutions BE employees:

• You contribute to guaranteeing the quality level and you work on continuous (quality) improvement.
• You are responsible for informing colleagues about quality, pharmaceutical legislation and rules.
• You are responsible for encouraging employees to respect the pharmaceutical rules.

4. You actively follow the commitments made to our internal stakeholders regarding batch record review and quality system records and report them to the supervisor.

Profile:

• You have a Master’s degree (preferably in Chemistry, Industrial Pharmacy, Biotechnology, Biomedical sciences etc.) or equivalent through experience;
• You have at least 3 years of experience in a similar position in the pharmaceutical, medical device or biotech sector;
• Knowledge of quality systems is a requirement; experience with European and American GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is asset.
• You work efficiently with MS Office package; knowledge of SAP/ MasterControl is an asset.
• You can communicate fluently in English (both spoken and written). A perfect command of either French or Dutch is essential. Knowledge of the other national language is a definite asset.
• You are analytical and good at solving problems.
• You are result-oriented and decisive.
• You are pragmatic.
• You are customer-oriented, persuasive, communicative, and cooperative.
• You are stress resistant.
• You are flexibel and willing to provide telephone support outside the office hours and during the weekend on scheduled planning.

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

• 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 and 1 day homeworking after a successful onboarding (after 6 months).

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!