Job Title
Quality Assurance Manager
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Job Description
As a Quality Assurance Manager, you will be responsible for driving quality assurance activities on the site of a leading Pharmaceutical multinational.
Key responsibilities include maintaining compliance within assigned areas, working closely with cross-functional teams to uphold the highest standards of quality and regulatory adherence.
The ideal candidate will have experience in Quality Assurance, Quality Control, or Technical Operations within FDA/EMEA regulated environments.
A degree in Science, Quality, or a related technical field is required.
You will take ownership of preparing and reviewing GMP documentation, ensuring full compliance with regulatory expectations.
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.
Develop and maintain QA policies, SOPs, and reports that support site operations and compliance.
Champion continuous improvement initiatives by identifying opportunities to enhance quality processes and operational efficiencies.
Participate in risk management activities, applying relevant guidance and industry best practices to mitigate potential quality risks.
Support and execute the internal audit program, including conducting audits as required to ensure ongoing compliance and improvement.