QUALITY SPECIALIST

QUALITY SPECIALIST

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.

Responsibilities

• 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

Requirements

• 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.