Reporting to the GDP Quality Manager the GDP Quality Specialist is responsible for ensuring compliance with EU Good Distribution Practice (GDP) Guidelines 2013/C 343/01, operating under the HPRA Wholesale Distribution Authorisation (WDA). In addition, supporting compliance under the Manufacturing Authorisation (MA) for Plasma Operations, Semi- Finished Product Distribution Activities and other activities as assigned by the Quality Manager and / or Technical Director.
The successful candidate will be expected to contribute to the continuous improvement of the Quality Management System.
The successful candidate will have had previous experience in a similar GDP role.
The successful candidate will require flexibility in relation to working hours in order to support Quality Activities related to Plasma Operations.
- Assist in the creation of Standard Operating Procedures (SOP's) in relation to the Documentation System for GDP impacting areas.
- Communicate with cross functional departments to ensure continued support of compliance under the WDA and MA.
- 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 area and Plasma Area
- Co-ordination of customer complaints in relation to GDP
- Manage GDP related KPIs and monthly compliance reporting across GDP operations.
- Assist in ensuring staff operating in GDP areas, are competent and trained initially and continuously in GDP related activities.
- Completion of delegated tasks relevant to the site temperature monitoring processes
- 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.
- Management of documents on the DCM system as required.
- Ensure Bona Fides are maintained and periodic review is complete for Suppliers and Customers
- Completion of Master Data to Support Reception and Storage Process of Plasma from Plasma Donor Centres.
- Responsible for review and approval of Plasma documentation and information received during Plasma deliveries
- Responsible for the performance of Quality checks assigned during Plasma Operations
- Excellent people and time management skills
- Strong technical writing and analytical skills
- Excellent communication and teamwork
- Ability to work proactively on own initiative
- Experience working in distribution/manufacturing and supply chain experience in the pharmaceutical or related industry working under quality management systems in an environment of continuous improvement.
- Experience in using Microsoft packages.
- Degree in a science, pharmacy or related discipline.
- Experience of working in a team environment and participating in Project teams.
- Experience in Documentum.
- SAP Pharma Experience.
- Previous experience as an RP / Deputy RP.
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