GDP Quality Specialist

At Grifols we believe that diversity adds value to our business our teams and our culture. We are committed to equal employment opportunities that foster an inclusive environment.

POSITION SUMMARY:

Reporting to the GDP Quality Supervisor the GDP Quality Specialist is responsible for ensuring compliance with EU Good Distribution Practice (GDP) Guidelines 2013/C 343/01 and the HPRA Wholesale Distribution Authorisation (WDA).
The GDP Quality Specialist will also assist in ensuring compliance to the Manufacturers Authorisation where it is impacted due to distribution activities particularly the receipt and storage of plasma and intermediate products.
The GDP Quality Specialist is responsible for ensuring the continuous improvement of the Quality Management System (QMS).

What youll Do

• Ensure that the quality management system is implemented and maintained
• Focusing on the management of authorised activities and the accuracy and quality of records
• Assist in the creation/maintenance of Standard Operating Procedures (SOPs) in relation to the Documentation System for GDP impacting areas and plasma operations.
• Communicate with cross functional departments to ensure continued support of compliance under the WDA.
• Communication with the manufacturing and distribution sites of Grifols in relation to QMS activities where appropriate.
• Support compliance with the general conditions of Wholesale Distribution/Manufacturing Authorisations guidelines and other legal requirements.
• Preparation and review of SOPs/documentation in the GDP and Plasma area.
• Co-ordination of customer complaints in relation to GDP
• Co-ordination of deviations related to distribution and plasma operations.
• Ensure staff operating in GDP areas are competent and trained initially and continuously in GDP related activities.
• Delegated tasks relevant to the site temperature monitoring system (including monthly reports and review of calibration certificates)
• Ensure the GDP Quality Manager or the Technical Director is appraised on all quality related issues relating to GDP
• Provide support to the GMP area as required.
• Provide support to the DCM system as required.
• Ensure Bona Fides are maintained and periodic review is complete for Suppliers and Customers.
• Approval of new customer accounts to be created on SAP.
• Act as a Lead Auditor/Auditor in internal audits as assigned by the Technical Director
• Completion of audits of Distributors/Transport Service Providers
• Co-ordination of Quality Agreements were assigned
• Review of Site Pest Control Reports
• Management of assigned projects using QMS tools
• Complete and facilitate risk assessments were assigned
• Assist the RP and DRP in the review and coordination of returns of medicinal products to GWWO
• Assist the RP and DRP in the performance of Recalls / Mock Recalls

What youll bring

• Minimum of three years experience working in quality distribution or supply chain in the pharmaceutical or related industry working under quality management systems in an environment of continuous improvement.
• Experience in using Microsoft packages.
• Excellent communication skills (verbal and written) Experience of working in a team environment and participating in Project teams.
• Experience working with an electronic Documentum Management System (DMS).
• Experience working with Veeva Management System

Qualifications

• Degree in a science pharmacy or related discipline.
• Excellent people and time management skills
• Strong technical writing and analytical skills
• Excellent communication and teamwork
• Ability to work proactively on own initiative
• SAP Pharma experience preferably
• Understanding and experience of EU/GDP GDP Requirements
• Experience and understanding of a QMS

Our Benefits Include:

• Highly competitive salary
• Group pension scheme - Contribution rates are (1.5% / 3%/ 5%/ 7%) and company will match
• Private Medical Insurance for the employee
• Ongoing opportunities for career development in a rapidly expanding work environment
• Succession planning and internal promotions
• Education allowance
• Wellness activities - Social activities eg. Padel Summer Events
  
  

We understand that self-doubt can hold talented individuals back from applying for opportunities. We encourage everyone who meets the qualifications to apply were excited to hear from you

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Location:Grange Castle International Business Park Grange Co. Dublin D22 K2R3