Quality Assurance Lead
5 days ago
Senior QA Specialist Job Description
OverviewThis role is a key driver of quality assurance activities, ensuring all operations align with regulatory expectations and cGMP principles. As a Senior QA Specialist, you will be responsible for maintaining compliance within your assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.
The successful candidate will have strong written and verbal communication skills, capable of clearly articulating complex quality issues. They will also have hands-on experience with quality management systems such as Veeva, SAP, or similar platforms.
Key Responsibilities- Lead the QA review and approval process for Change Controls, Deviations/CAPAs, SOPs, and related documentation.
- Manage QA operational duties related to product disposition, ensuring timely and compliant decision-making.
- Monitor and evaluate new regulatory guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
- Degree in Science, Quality, or a related Technical field.
- 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
Employees are the heartbeat of our organization. We provide empowering career development through Learning & Development, in-house training, mentorship, and constant guidance to facilitate career progression.
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