Quality Assurance Manager
This role involves ensuring the highest quality standards are met in the development and production of pharmaceutical products. It requires a strong understanding of quality management systems and GMP regulations.
The successful candidate will have excellent organizational skills, be able to prioritize multiple tasks, and communicate effectively with all levels of management. Experience working with contract manufacturers and electronic quality management systems is highly desirable.
Key responsibilities include reviewing and approving batch documentation, managing day-to-day activities with outsourced partners, and participating in continuous compliance improvement projects. The ideal candidate will have a BSc degree in Life Sciences and at least 6 years of experience in the pharmaceutical industry.
Additional responsibilities may include preparing QP documentation packages, supporting data preparation for periodic review of the Quality Management System, and working closely with the Global Technical Operations department to meet timelines and achieve business results.
Collaboration, resilience, flexibility, and accountability are essential qualities for this role. If you are a results-oriented individual with strong time management skills and a passion for quality assurance, we encourage you to apply.
Responsibilities:
* Review and approve batch documentation for API, Intermediates, and Finished Product produced for Amarin.
* Manage the day-to-day activities with outsourced partners such as manufacturing documentation, deviation, and change control review and approval.
* QA review of manufacturing batch documentation and preparation of QP documentation package.
* Support of QP information requests Management of all GMP product information to ensure ready retrieval. Management of provision of samples to test labs.
* Preparation of Annual Product Review Support of CMO metrics and oversight process to ensure timelines are met.
* Manage complaint investigations at outsourced partners to ensure thorough investigation and provision of report Update quality documents as required to ensure continued compliance.
* Participate in and lead continuous compliance improvement projects within the team.
* Support the vendor qualification program including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
* Be a key member of the company audit team including participation in regulatory, supplier, customer & internal audits as required.
* Support data preparation for periodic review of the QMS and management review as appropriate.
* Support the development and reporting of quality metrics.
* Support GDP activities as required.