Senior Quality Assurance Manager
1 week ago
We are seeking a Senior Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the highest standards of quality and regulatory adherence across all site operations.
As a key member of our cross-functional team, you will play a vital role in maintaining compliance with cGMP principles and regulatory expectations from agencies such as the FDA and EMA.
The ideal candidate will have a degree in Science or Quality and 5-10 years of experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
Key responsibilities include:
- Documentation: Ensuring full compliance with GMP and site-specific requirements.
- Quality Assurance operational duties: Managing product disposition and ensuring timely and compliant decision-making.
- Regulatory updates: Monitoring and evaluating new guidance and industry best practices, assessing their impact on quality systems and driving necessary updates.
- Policy development: Assisting in developing and maintaining QA policies, SOPs, and reports that support site operations and compliance.
Other key qualifications include strong written and verbal communication skills, capable of clearly articulating complex quality issues.
This is a contract opportunity in Pharmaceutical Manufacturing. Please note that candidates must possess either a Stamp 1G or a Stamp 4 visa. We are unable to provide visa sponsorship at this time.
Apply via this advert or contact Siobhan Cummins if you have any questions about this opportunity.
Responsibilities
- Ensure full compliance with GMP and site-specific requirements.
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