QUALITY SPECIALIST

Employer
Grifols
Location
Dublin, Dublin West
Salary
EUR40000 - EUR50000 per annum + bonus, health insurance , 25 days hols
Closing date
23 Dec 2021

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Sector
Manufacturing
Salary Range
Permanent, EUR, €40,000 - €49,999, €50,000 - €59,999
Job Type
Permanent
Hours
Full-time
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Job Details

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.

Company

Grifols is a global company that since 1909 has enhanced the health and well-being of people around the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative solutions and services in more than 100 countries.

Grifols Worldwide Operations Ltd. was established in 2013 in Dublin, Ireland. It serves as the management center for the global Bioscience Division overseeing treasury, risk management, supply and demand planning, regulatory, R&D and commercial functions.

It also serves as a hub for labeling, packing, final conditioning and distribution of finished plasma products to Grifols' worldwide network of commercial subsidiaries and distributors, with the exception of Spain and the United States. The site will also host an Albumin purification plant which is now under construction. www.grifols.com

Grifols Plant

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Location
IE

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