At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help innovative companies unleash their potential through R&D and engineering services.
Your role
As a QA Specialist supporting MES in Sterile Manufacturing and in Device Assembly and Parenteral Packaging, you will use your understanding of sterile manufacturing processes to make informed quality decisions on the setup of the new PAS/X MES system. You will define quality requirements and review and approve relevant procedures and MES data to ensure alignment with GMP and applicable quality requirements.
Responsibilities
- Develop and maintain a thorough understanding of processes within the Sterile Manufacturing area to make quality decisions in line with GMP and applicable quality requirements.
- Provide quality support for the MES project in the Sterile Manufacturing area.
- Review and approve quality-relevant master data, manufacturing instructions and process changes.
- Participate in projects to optimise workflows for reviewing and approving master data, manufacturing instructions and process changes.
- Assure compliance with the marketing authorization and Good Manufacturing Practices.
- Maintain strong working relationships with the MES team, Business and Quality partners, and act as Quality Point of Contact.
- Support quality oversight of operational activities by ensuring QA review and approval of GMP documentation.
- Act as the quality representative for projects, providing quality oversight and ensuring alignment with GMP and applicable quality and compliance requirements.
- Provide general administrative support to the QA MES Lead.
Your profile
- University degree with a scientific orientation, such as pharmaceutical, chemical or biological sciences or engineering.
- 5–10 years of experience in the pharmaceutical industry, with knowledge of aseptic manufacturing, Annex I, batch record setup and batch release activities.
- Quality-driven mindset and familiarity with GMP legislation.
- Excellent computer proficiency and experience with MES.
- Ability to work independently while staying connected with key stakeholders.
- Ability to work effectively in a team and maintain open, constructive dialogue.
- Ability to handle time pressure and changing priorities and make risk-based decisions.
- Proactive, analytical and problem-solving approach with knowledge of risk management principles.
- Commitment to continuous improvement.
- Thorough knowledge of pharmaceutical legislation, cGMP regulations, ICH guidelines, policies and procedures.
- Excellent communication and networking skills.
- Understanding of the business implications of quality positions and decisions.
- Fluency in Dutch and English, written and spoken.
- Mobility to the client located in Beerse, Belgium.
What you'll love about working here
- Engineering Horizons, a global conference for Capgemini Engineering colleagues.
- FlexAbroad, allowing employees in more than 20 countries to work abroad for up to 45 days in a 12-month period.
- Digital Campuses and Academy with more than 60,000 hours of training.
- Global technology challenges and ideation campaigns focused on positive societal impact.
Capgemini is a global business and technology transformation partner with 340,000 team members in more than 50 countries.