As a QA Associate you ensure that quality is safeguarded for all (International) clients and products. You like the dynamics of quality assurance in a production site whit a great diversity of products.
As QA Associate Manufacturing you work to ensure the phase I, phase II and commercial products made meet all the quality requirements: safety, efficacy, potency and purity. This concerns both the requirements from the customer as the regulatory requirements.
You validate that the products comply with the product label claim and maintain the quality system.
As a QA Associate Manufacturing you will:
- Be responsible for on the floor quality oversight of the production of products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- Work with Project Managers and Operations organization to successfully transfer process from the client to GMP facility to manufacture products.
- Support drafting of standard operating procedures and batch records.
- Real time review of all documentation and reporting in support of process unit operations.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
Your excellent communication skills and your strong personality make it easy to connect with the diverse stakeholders in and outside the organisation. You have excellent organisation, facilitating and communication skills. You will need this to be able to carry projects in the organisation and in contact your contact with International Customers. And to harvest quality awareness in the company.
- A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required
- Working experience in Quality Assurance related to manufacturing
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing
- Excellent written and oral communication skills are required