The QA Ops Filling Specialist role plays a pivotal part in ensuring the quality and compliance of our Aseptic Filling and Set-Up activities.
This position acts as the Quality representative for all quality/compliance related topics, maintaining a strong partnership between Quality and Operations to support Compliance to cGMP's, GDP's and Takeda Procedures.
A key responsibility is the adequate deployment, implementation and utilization of all quality systems as defined by Takeda Procedures. The Quality Representative must also ensure timely closure of Deviation/LI Reports according to applicable procedures.
The Quality Operation within this area of responsibility involves acting as a quality link on the floor to support adequate quality systems deployment and application. This includes participating in Tier and supporting any quality decision in coordination with Manufacturing.
Key responsibilities include performing GMP walkthroughs / observations during routine operations to ensure the application of the cGxP's, the compliance to the procedures, and all the aspects linked to the safety, the reliability and the consistency of the operations.
The ideal candidate will have a Master degree in Science (Biological, Chemical, Biochemical, …) or equivalent with experience. Additionally, they should possess min 3 years of experience in a Pharmaceutical environment, with general overview of Quality Systems.
The following skills are required:
* Critical thinking, autonomy and problem solving
* Good level of reading/writing English
* Communication skills
* Organizational skills, focusing on priorities
* Collaboration and Teamwork
* Flexibility
* Techncal writing skills
* Assertivity
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Please note that we require a good level of reading/writing English and a minimum of 3 years of experience in a Pharmaceutical environment.
This role requires a strong understanding of Quality Systems and excellent communication skills.
If you are a detail-oriented individual with a passion for quality and compliance, we encourage you to apply for this exciting opportunity.