▷ [Urgent] Quality Assurance Manager
8 hours ago
Our vision is to one day reach the moment when heart disease is no longer the #1 cause of death in Europe. Bold, we know. But it’s what drives us every single day. Knowing that because of what we do, someone, somewhere is less likely to have a heart attack or stroke. That’s making a real difference if you ask us.
Even though we’ve been around for a while, in Europe, we’re starting from scratch. Building the organization, setting up the processes, educating people, delivering therapies. And we’re doing it in record time. In today’s life science industry, that’s unique. Some might even say “once-in-a-lifetime”.
So if you’re looking for a company where you’ll be at the start of an amazing journey, a company that’s introducing a new era in cardiovascular care in Europe based on groundbreaking science, a company where you can really apply your experience, are empowered to innovate, where hard work is rewarded, and above all where you can make a true difference in people’s lives, Welcome
But let’s be perfectly clear, given our current start-up phase, the pressure is high. Resilience, flexibility, results-oriented and accountability aren’t vague notions here. We expect a lot from each other – and so we should. After all, patients count on us.
And at Amarin, we also count on each other. Teamwork and collaboration are essential. We support each other, challenge each other and help each other. Across all functions and countries. We focus on moving forward, aren’t afraid of mistakes and leaders are just a (video) call away. Because we know that together, we achieve more. Working with some of the brightest in the industry, each as knowledgeable, determined and committed to our vision as the next, you’ll achieve more too.
Primary Objectives:
1. Review and approve batch documentation for API, Intermediates and Finished Product produced for Amarin.
2. Manage the day-to-day activities with outsourced partners such as manufacturing documentation, deviation, and change control review and approval.
3. QA review of manufacturing batch documentation and preparation of QP documentation package.
4. Support QP information requests and manage all GMP product information to ensure ready retrieval.
5. Preparation of Annual Product Review and support of CMO metrics and oversight process to ensure timelines are met.
6. Manage complaint investigations at outsourced partners to ensure thorough investigation and provision of report.
7. Update quality documents as required to ensure continued compliance.
8. Participate in and lead continuous compliance improvement projects within the team.
9. Support the vendor qualification program including initial and ongoing qualification to ensure quality oversight of GxP Vendors.
10. Be a key member of the company audit team including participation in regulatory, supplier, customer & internal audits as required.
11. Support data preparation for periodic review of the QMS and management review as appropriate.
12. Support the development and reporting of quality metrics.
13. Support GDP activities as required.
14. Work in close partnership with Global Technical Operations department and other cross functional partners to meet timelines and achieve business results.
Education/Training: BSc. Degree in Life Sciences is required.
Skill(s):
1. Strong inter-personal skills including the ability to work effectively in a global team environment and to build collaborative relationships with peers and other stakeholders.
2. Highly organized with the ability to prioritize, manage multiple tasks and meet deadlines.
3. Ability to communicate effectively with all levels of management both verbally and in writing.
4. Strong experience working with electronic systems and IT platforms.
5. Ability to work independently and within a team as an individual contributor.
6. Ability to lead a project team.
Experience:
1. Ideally a minimum of 6 years experience in pharmaceutical industry in areas such as quality assurance, quality systems, auditing, compliance, pharmaceutical manufacturing or new product introduction.
2. Strong understanding of quality management systems and GMP is required.
3. Experience in pharmaceutical manufacturing required in any of the following areas: laboratory, production, validation, QA.
4. Experience working with contract manufacturers and in a virtual environment desirable.
5. Experience working with electronic quality management systems.
Organizational Values:
1. Operational Excellence
2. Commitment to Quality
3. Integrity
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