Senior QA Validation Engineer - Lead CAPA & Projects

Prothya Biosolutions; Brussel Hoofdstad; Sur place; EUR 70 000 - 90 000; Plein temps

Description du poste

Reports to the Supervisor QA Validation (A.I.)

Objectives

As a Senior Quality Engineer, you safeguard quality levels by monitoring and ensuring that all operations at all levels are carried out in accordance with the cGMP quality systems applied within Prothya Biosolutions. In this way, you contribute to Prothya Biosolutions’ pharmaceutical products meeting European and US cGMP guidelines. You are part of a team of Systems Validation Quality Engineers.

Main Responsibilities and Result Areas

Monitoring and/or delivering quality‑related activities in accordance with the cGMP quality systems applied within Prothya Biosolutions:

• Oversee written documents concerning the quality systems of other departments such as procedures, protocols and reports.
• Correct and authorise those procedures, protocols and reports.

Taking part in the various projects concerning the implementation of the quality systems in your department (and organisation as a whole):

• Oversee initial and routine validations/qualifications.

Taking part in and/or leading quality‑related projects:

• Carry out risk analyses and determine correction and prevention measures (CAPAs).
• Act as QA Lead and primary point of contact between the project team and your department: collaborate and support the project team on all quality issues.
• Attend project meetings when necessary.
• Serve as QA SPOC for projects under your responsibility.

Providing support (coaching and supervision) to junior members of the QA validation team and to Prothya Biosolutions employees as a ‘quality contact person’ in your department:

• Inform colleagues about quality, legislation and pharmaceutical rules.
• Encourage employees to act in accordance with pharmaceutical rules.
• Contribute to safeguarding the level of quality and collaborate in continuous improvement of quality.

Profile

• Master’s degree (preferences: Chemistry, Industrial Pharmacy, Biotechnology, etc.).
• 6 to 10 years of experience in a similar position in the pharmaceutical or food sectors.
• Familiarity with European and US GMP guidelines and SOPs is an asset.
• Proficient in MS Office and knowledgeable about quality assurance management systems (SAP, MasterControl, etc.).
• Familiar with Good Documentation Practices, Data Integrity and Computer Systems Validation.
• Experience with sterilization validation in QA or Engineering (equipment validation).
• Analytical and problem‑solving oriented.
• Comfortable taking the lead when necessary and acting as SPOC for stakeholders and as a supporting role for your line manager.
• Results‑oriented and decisive.
• Customer‑oriented, persuasive and collaborative.
• Fluent in English (both spoken and written) and possess good knowledge of Dutch and/or French.
• Flexible and available to work during the annual summer shut‑down (August).
• Based in Brussels (Neder‑over‑Heembeek).

Benefits

• Competitive salary, group and health insurance, meal vouchers, and eco‑cheques.
• Flex Reward Plan allowing customisation of certain salary components.
• Holiday system exceeding the legal holidays and 1 day of home working after successful onboarding (after 3 months).
• Long‑term career prospects and active on‑the‑job training.
• Attractive, safe and challenging working environment with opportunities for growth and innovation.