Senior Engineer QA Validation | Brussels

Prothya Biosolutions (operating under Accord Plasma B.V. / Intas Pharmaceuticals); Brussel Hoofdstad; Sur place; EUR 90 000 - 120 000; Plein temps

Avantages offerts par ce poste

Health insurance

Meal vouchers

Eco-cheques

Flex Reward Plan

1 day homeworking after onboarding

Résumé du poste

Prothya Biosolutions, a Belgium-based biopharmaceutical company, seeks a Senior Quality Engineer to safeguard quality by overseeing qualification and validation protocols from a QA perspective. You will review validation protocols and reports and draft validation tests for equipment, utilities, IT, cleaning, and process validation.

You will lead quality-related projects and act as the primary QA SPOC for project teams, while coaching junior QA validation staff and promoting adherence to pharma

Qualifications

• Master's degree in a relevant field is required.
• 6–10 years of experience in pharma/food sectors in QA/validation.
• Familiarity with European and US GMP guidelines and SOPs is a plus.
• Proficiency with MS Office and QA systems (SAP, MasterControl).
• Knowledge of Good Documentation Practices, Data Integrity and Computer Systems Validation.
• Experience with sterilisation validation in QA or Engineering.

Responsabilités

• Oversee qualification and validation protocols from a QA perspective.
• Draft and review validation reports and protocols for equipment and utilities.
• Lead quality-related projects and act as SPOC for project teams.
• Provide coaching to junior QA validation staff and educate on quality and pharma rules.
• Support IT validation, cleaning validation and process validation.

Connaissances

Quality Assurance

Validation

GMP

Project leadership

SPOC

English fluency

Dutch/French knowledge

Formation

Master's degree in chemistry/industrial pharmacy/biotechnology

Outils

SAP

MasterControl

Description du poste

Reports to the Supervisor QA (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’s pharmaceutical products meeting European and US cGMP guidelines. You are part of a team of Systems Validation Quality Engineers.

• As a Senior Quality Engineer with a specific focus on qualification and validation, your tasks will primarily relate to overseeing qualification and validation protocols from a QA perspective. You support the drafting of reports on the validation of cleaning and processes. You take care of reviews of validation protocols and reports, and you support the drafting of protocols and qualification test reports for equipment (production, QC, etc.), utilities such as water systems, HVAC systems, IT validation, cleaning validation and process validation.

Main responsibilities and result areas:

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

o Overseeing written documents concerning the quality systems of other departments such as procedures, protocols and reports;

o Correcting and authorising 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)
  • Overseeing changes via Change Control;
  • Overseeing initial and routine validations/qualifications;
  • Taking part in and/or leading quality-related projects.
  • Carrying out risk analyses and determining correction and prevention measures (CAPAs);
• Taking part in different Prothya Biosolutions projects as QA Lead and acting as primary point of contact between the project team and your department:
  • Collaborating and supporting the project team on all their quality issues;
  • Attending project meetings when necessary.
  • Taking on the role of QA SPOC for projects under your responsibility
• Providing support (coaching and supervision) to junior member of the QA validation team as well as Prothya Biosolutions employees as a ‘quality contact person’ in your department:
  • Informing your colleagues about quality, legislation and pharmaceutical rules;
  • Encouraging employees to act in accordance with pharmaceutical rules.
  • Contributing to safeguarding the level of quality and collaborating in the continuous improvement of quality

Profile:

• You have a Master’s degree (preferences: Chemistry, Industrial Pharmacy, Biotechnology, etc.);
• You have at least 6 to 10 years of experience in a similar position in the pharmaceutical or food sectors;
• Familiarity with the European and US GMP (Good Manufacturing Practices) guidelines and SOPs (Standard Operating Procedures) is an asset;
• You are proficient in the use of MS Office tools and have good knowledge of management systems, in particular those used for quality assurance (SAP, MasterControl, etc.);
• You are familiar with the concepts of Good Documentation Practices, Data Integrityand Computer Systems Validation;
• You have experience with sterilisation validation in QA or Engineering (Equipment validation by example);
• You are analytical and keen to solve problems;
• You like to take the lead when necessary and act as SPOC for the different stakeholders and in a supporting role for your line manager.
• You are results-oriented and decisive;
• You are customer-oriented, persuasive and enjoy collaborating;
• You can communicate fluently inEnglish (both spoken and written), and you have a good knowledge of Dutch and/or French;
• You are flexible and able to work during the annual summer shut down (August)
• You are based in Brussels (Neder-over-Heembeek).

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 investments 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 and 1 day homeworking after a successful onboarding (after 3 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!