Quality Associate
il y a 1 mois
BrusselsAs a Quality Associate in the pharmaceutical industry, you play a crucial role in ensuring that the products are safe, effective, and meet regulatory requirements. You work with cross-functional teams to develop and implement quality systems, investigate quality issues, and drive continuous improvement.
**| Your challenges?**:
- You ensure that the manufacturing processes comply with the Good Manufacturing Practice (GMP) regulations.
- You develop, implement and maintain quality systems such as Quality Management Systems (QMS), Quality Control Systems (QCS), and Standard Operating Procedures (SOPs) to ensure the consistent production of high-quality products.
- You conduct risk assessments and perform root cause analysis, striving for continuous improvement
- You develop and manage corrective and preventive actions (CAPA’s).
- You develop and conduct training programs to ensure operational activities comply with the quality systems and regulations.
- You are responsible for review of Batch documentation.
- You provide support in preparation for regulatory inspections and audits and ensure that all quality records are accurate and up-to-date.
- You work with other departments such as Manufacturing, Regulatory Affairs, R&D, and Supply Chain to ensure that quality issues are addressed and resolved.
- You develop and implement continuous improvement programs to enhance the quality of products and processes.
- You maintain up-to-date knowledge of industry standards and regulations and ensure compliance with any changes.
- You ensure that all documentation related to quality systems and processes are accurate, complete, and maintained in accordance with the company's policies and procedures.
- You take possible complaints from suppliers into consideration in order to ensure follow up with the appropriate CAPA’s.
**| What do we expect from you?**:
- You have a Master’s degree in Life Sciences
- You have experience in GMP environment and with ISO 9001 or similar quality management systems.
- You have know-how of pharmaceutical legislation.
- You have experience with QMS software such as Trackwise.
- You have an eye for detail, strong analytical and problem-solving skills.
- You are able to work independently and as part of a team.
- You have good communication skills to cope with all key stakeholders.
- Fluent in Dutch and English.
**| What can you expect from TMC?**:
TMC is an international high-tech consultancy company that brings expertise to its clients in order to support them with the realization of their technological challenges. As such, TMC is operating as an expert center at the disposition of its clients and we help them to be more competitive in an ever more global and faster changing technological world.
At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.
As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.
**| Why choose for Employeneurship?**:
We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21st century for high skilled technical professionals. It is built around 5 main pillars:
- You will have a permanent employment contract, offering you stability and security
- You will get to know your market value and have a share in the profit your work generates thanks to the individual profit sharing
- We will support you with one-on-one coaching and training designed to help you develop your entrepreneurial skills
- The competence cells structure provides you with a strong meaningful and relevant network
- The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups
- TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status._
**Feel Free to Contact**:
**Elly-May Donkor**:
HR Business Partner
Tel: +32 497 71 57 66
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