Supply Chain Manager & Responsible Person
- Dublin North, Dublin
My client, a leading healthcare company based in North Dublin, have an immediate opening for a Supply Chain Manager & Responsible Person.
Reporting to the Group Financial Controller and Chief Executive Officer, the Supply Chain Manager (SP) (will be a senior member of the management team and will be leading and managing the Supply Chain and Logistics Department. The Supply Chain Management will be responsible for all supply chain (sourcing, production, distribution) oversight and responsible for distribution practices within the Quality Management System(s).
Central to this role, this position will be responsible for actively promoting an operationally optimising supply chain and distribution activities within a growing business and will collaborate closely with other departments across the business including: Quality, Regulatory and Pharmacovigilance, Research and Development, Customer Services and Finance. The position, at present, has 1 direct report (Supply Chain Coordinator).
Key Duties and Responsibilities
* The role of the Supply Chain Manager and Responsible Person is to coordinate the sourcing, planning, manufacture and supply of finished products and act as Responsible Person for Distribution.
* Manage contract manufacturers, suppliers and warehouse /logistics service providers, such that they meet business needs in terms of timelines, cost and quality.
* To make product available within business supply chain in a timely manner, of the appropriate quality and at most cost effective price.
* To manage the supply chain function to ensure costs meet agreed budgets for the year.
* To manage supply chain co-ordinator workload and professional development.
* To oversee and assure Quality of GDP operations to ensure that the quality, safety and traceability of medicinal products are maintained within the supply chain.
Key Duties and Responsibilities across the following key areas:
* Responsible Person
* Health and Safety
1. Is responsible for ensuring the conditions of the business' Wholesale Distribution Authorisation are complied with and that the business wholesale and distribution activities comply with current legislative requirements including EU Good Pharmaceutical Distribution Practice and guidance from the HPRA.
2. Act and perform duties under the provisions of the company's Wholesale Distribution Authorisation
3. Shall ensure the conditions of the WDA are maintained and provide recommendations to senior management on where the business could improve its compliance with GDP.
4. Advise senior management on Good Distribution Practice (GDP), outlining where company may not be following GDP and providing recommendations to ensure compliance with GDP.
5. Ensure that company operations do not compromise the quality of medicines by ensuring that secure systems are in place throughout the supply chain under the control of the business.
6. Ensure that there is an adequate Quality Management System (QMS) in place and that it is maintained in compliance with GXP requirements
7. Ensure Standard Operating Procedures and all master quality documents in relation to the operation of the licence are approved.
8. Ensure all key personnel are trained, that continuous training programmes.
9. Assist company, following a decision to recall a product for which company is the product Marketing Authorisation Holder. The RP shall ensure that information on the distribution of product is provided as required on behalf of the company as MA holder, as per company SOP Recall Procedure.
10. Shall ensure that customer complaints are dealt with efficiently and effectively as per SOP on Complaints Handling.
11. Shall ensure that Quality Technical Agreements which impact cGDP are in place with all contractors and ensuring that suppliers and customers are approved;
12. Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
13. Keeping appropriate records of any delegated duties;
14. Ensuring that any additional requirements imposed on certain products by national law are adhered to.
15. Decide on the final disposition of returned, rejected, recalled or falsified products
16. Be contactable by the HPRA, the Competent Authority at all times and provide the HPRA with the appropriate contact details.
17. Have sufficient knowledge on the products the company distributes and on the complexity of the operation. (The RP shall keep themselves up to date with any changes in the legislation and with on-going training as identified.)
18. Ensure that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC.
If you are interested in hearing more about this excellent opportunity, please apply directly to this advert for immediate consideration.
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