GDP QUALITY SPECIALIST

Recruiter
Grifols
Location
Dublin West, Dublin
Salary
EUR40000 - EUR50000 per annum + bonus, health insurance , 25 days hols
Posted
25 Nov 2021
Closes
23 Dec 2021
Ref
GDP QUALITY SP
Contact
Ann Marie Corcoran
Sector
Manufacturing
Job Type
Permanent
Hours
Full-time

GDP 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.

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