Senior Quality Assurance Specialist
hace 2 semanas
At Takeda Pharmaceutical, we are seeking a highly skilled and experienced Senior Quality Specialist to join our team. This role will be responsible for ensuring the quality of our products and processes, and for maintaining compliance with regulatory requirements.
About the Role:This is a critical role that requires a strong understanding of pharmaceutical quality management systems, including EU GDPs, ISO standards, and GMPs. The successful candidate will have a minimum of 6 years of experience in a QA environment, with a strong track record of supporting inspections and audits.
Key Responsibilities:- Quality oversight of outsourced distribution partners
- Ensure compliance with legal and corporate requirements, as well as I-SOPs and Local SOPs
- Establish corrective and preventive actions and promote continuous improvement in critical processes from a quality point of view
- Local quality surveillance - connect with customers: Returns, market actions, complaints, inquiries
- Support geographic expansions and brand plan launches
- Shipping validation and distribution processes quality oversight
- Identify risks in the quality area, propose CAPA, and follow up
- Bachelor's Degree in Pharmacy
- Practical experience of at least 6 years in the Pharmaceutical Industry, primarily in a QA environment
- Experience in supporting inspections from local authorities/global audits
- Strong interpersonal skills and the ability to work cross-functionally and cross-culturally
As a Senior Quality Specialist at Takeda Pharmaceutical, you will have the opportunity to work with a talented team of professionals who are passionate about delivering high-quality products and services. You will be responsible for ensuring that our products meet the highest standards of quality, and for maintaining compliance with regulatory requirements.
We are looking for a highly skilled and experienced professional who is passionate about quality and compliance. If you are a motivated and results-driven individual who is looking for a challenging and rewarding role, we encourage you to apply.
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