Astellas UK and Astellas EMEA currently have two opportunities to join the Global Quality Assurance team to ensure all transactional procurement and supply activities of finished medicinal products are conducted in accordance with EU GDP Guidelines (2013/C 343/01) and applicable local regulations.

Specifically, the UK opportunity requires an individual that is a qualified RPI (Responsible Person for Import).

Responsible Person Responsibilities:

• Wholesale Distribution Authorisations are maintained, and their provisions met.
• Appropriate standards of Good Distribution Practices (GDP) are maintained during procurement and supply activities. (Note: these are solely transactional in nature and do not directly involve physical handling of product).
• An adequate quality management system in full alignment with Astellas’ corporate quality system is established and maintained.
• Self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
• Adequate records are maintained.
• There is clear definition of roles, responsibilities, accountabilities and delegated duties.
• All relevant personnel are robustly trained in GDP principles, their own duties, the risks of falsified medicines and the procurement and supply of products and product specific requirements as necessary. Training to be consistent and robust to ensure transfer of learning and embedded behaviours at the required standard.
• Full and prompt cooperation with customers / marketing authorisation holder representatives in the event of significant quality issues and/or product recalls. Ensure all steps recorded appropriately in the desired timelines.
• Appropriate agreements are in place as necessary with parties managing the physical handling and distribution of products to ensure GDP standards are suitably maintained such that operations do not compromise the quality of medicines.
• Ensure suppliers and customers are appropriately qualified and demonstrate that they hold the appropriate authorisations and licenses in relation to wholesaling. Ensure review mechanism in place to ensure such qualifications are current.
• Ensure relevant customer complaints are dealt with effectively, informing the manufacturer and/or marketing authorisation holder of any product quality defect issues. Ensure accurate and timely records are held with relevant parties (qualitative, quantitative information and audit trail).
• Ensure potential significant quality issues are escalated to Global QA in a timely manner and decisions regarding actions necessary as a result of significant quality issues are not taken without the involvement and endorsement of Global QA.
• Other such duties as may be reasonably required by the business.

Authority:

• The Responsible Person (APEL) has authority to take decisions with regards to the above responsibilities and is not duty bound by instruction which has potential to conflict of interest between good distribution practise and Operations.
• To raise any concerns and escalate in a timely manner in line with agreed policies and procedures to secure resolution and/or accountability to resolve.

Compliance:

• Embed Compliance Culture across the APEL Trading Party of the business ensuring Integrity in Action is actively applied in all initiatives.  
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• Ensure adherence to Astellas policies relating to Ethics and Compliance standards and interactions with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POs).

Contribute to the QA Management and communicate with QA:

• Review of the local QA Manual / SOPs and consolidation of the review by the site within agreed timelines and to required standard (documented, version controls, updates, owners etc.).
• Prepare monthly report to Global QA in agreed format (qualitative, quantitative data and explaining any variances).
• Conduct periodic Management Review for the APEL Trading Party in accordance with GDPs.
• Review elevated GDP issues, identify the issue and recommend action(s).

Required:

·       Eligibility to act as Responsible Person according to Article 79 (b) of Directive 2001/83/EC, EU GDP (2013/C 343/01) and/or applicable local legislation in the UK.

·       Desirable: eligibility to act as EU Qualified Person according to Article 49 of Directive 2001/83/EC and applicable local legislation.

·       Science based degree (Pharmacy preferred).

·       Extensive experience in progressively complex managerial roles.

·       Good organizational, coordination, diplomatic, negotiation, presentation and communications.

·       Contributing to global impact projects and/or previous experience leading small QA teams

·       English speaking and writing.

·       Common Sense approach to work.

·       Knowledge of IT systems compliance to GMPGDP.

·       GMP/GDP auditing experience.

If you are a seasoned Quality Assurance Responsible Person seeking an opportunity to be an integral member of the Global team and make a difference internally and externally within the current and future product portfolio of innovate medicines this is an opportunity not to be missed.

We offer:

• A challenging and diversified job in an international setting
• Good career opportunities
• Inspiring work climate
• Attractive remuneration package

Astellas Pharma is an affiliate of Tokyo-based Astellas Pharma Inc., a top 20 global pharmaceutical research company. Astellas is committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.