Posted on Mar 14, 2021 by Michael Bailey Associates - Amsterdam
is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Covis Pharma is a standalone company with commercial, Regulatory and Quality Assurance functions based in Amsterdam, The Netherlands.
Founded in 2011 and previously monetized part of the business for $1.2 billion in 2015.
We are seeking an experienced individual to support the team as Manager of QA for a period of 6 months. This opportunity presents a unique challenge to leverage the well-established heritage of these drugs while simultaneously building a new, unique culture focused on growth, profitability, and long-term vision. What you can expect from this role is the opportunity to work in a start-up type environment where your position will be broad, communication between departments is fast and effective and you will have significant responsibility and autonomy for your work and contribution. Our company is highly acquisitive of both commercial and late stage development assets in the EU.
The Manager of QA support the Qualified Person on the assessment of a) cGMP compliance of medicinal product' production; b) cGDP compliance of medicinal product's distribution; and c) the maintenance of a functional and inspection ready internal Quality System.
In this role, he/she supports the QP for the final decision on batch release or rejection.
- Support the record review for release and distribution of medicinal products to the EU markets (GMP and GDP guidelines)
- Work across all Pharma functions (Supply Chain, Regulatory Affairs, Development, Technical, etc.) to ensure that all applicable internal Quality Standards/Policies and regulatory requirements are maintained.
- Supports identification of gaps/risks and opportunities for continuous improvement in the Quality System and their remediation and implementation.
- Support the Health Authorities inspection preparation and management.
- For areas of his/her responsibilities continuously follows new regulatory regulations and guidelines and discusses/proposes their implementation at when deemed necessary.
- Ensure that GxP related internal documents (policies, SOPs, etc.) are up to date, timely reviewed and made effective and support the global training coordinator for local training in the Netherlands.
Required Background and Skills:
- Master's degree (minimum of four years) in life Science
- A minimum of 10 years' experience in pharma/biotech industry, of which a minimum of 5 years in QA.
- Previous experience with batch record review and good distribution practice is a strong plus.
- Experience with the application of Quality Systems in manufacturing, warehousing and distribution
- Team player and excellent communication skills.
- Excellent organizational skills and great attention to details.
- English is the company language. Knowledge of Dutch is a plus.
Michael Bailey International is acting as an Employment Business in relation to this vacancy.