Quality Assurance Specialist

Employer
Grifols
Location
Dublin, Dublin West
Salary
shift, health insurance, 25 days holidays
Closing date
11 Aug 2021

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Sector
Scientific
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Job Details

QA Packaging Specialist

 

To complete and support activities within the Quality Assurance Packaging Team relating to batch documentation review and product release.
To provide Quality support for the manufacturing operations in Grifols Worldwide Operations Ltd (GWWO).
This role will require the incumbent to take part in Yellow Belt Training and implement the identified improvements within the allocated timeframe.

 

RESPONSIBILITIES

 

1 General:
1.1 Act as a delegate for the QA Packaging Supervisor when required
1.2 Act as a representative for the QA Packaging team during shift hours, in the absence of the QA Packaging Supervisor/Manager
1.3 Act as a representative for the QA Packaging group at site Tier meetings in the absence of the QA Packaging Supervisor/Manager
1.4 Participate in department/site projects and initiatives to promote Quality Culture and compliance
1.5 To be proactive and improvement driven.

 

2 Communication:
2.1 Daily briefing on Quality batch review/approval
2.2 Provide quality performance information as required
2.3 Ensure regular Quality interaction with other Departments


3 Quality Assurance Activities:
3.1 Where applicable, perform Quality documentation review for receiving and shipment of Plasma
3.2 Quality in-process control including vial defect inspection
3.3 Involved in customer complaint investigation if required
3.4 Support the annual product quality reviews if required
3.5 Support for any quality related change controls as required
3.6 Perform internal quality audit/inspection programmes
3.7 Support the spot check/walk-through process of the lines
3.8 Act as back room support during any external audit/inspections
3.9 Represent Quality in the project management for any Process/product/system improvement projects
3.10 Provide Quality input to process/product investigations and lead investigations for any deviations assigned, including Plasma deviations
3.11 Complete any Laboratory related Technical Deviations (TDFs) and provide assistance to the quality supervisor for any ID Lab testing investigations
3.12 Training of new Quality personnel where appropriate and development of new training
3.13 Review of Batch Records and SOPs
3.14 GMP implementation and site-wide Quality Awareness
3.15 Follow up corrective actions identified through the Deviation system
3.16 Liaise with other Department representatives to promote improvements in GMP and Quality standards
3.17 Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities and highlight to management of any changes that potentially impact GWWO
3.18 Other duties as required by the QA packaging Supervisor/QA packaging Manager

 

REQUIREMENTS

 

  • Excellent communication skills
    * Competence in Microsoft packages specifically word, excel and PowerPoint
    * Ability to work proactively on own initiative
    * Ability to work independently
    * Excellent technical writing and analytical skills
    * Good organizational and time Management skills
    * Flexibility
    * Results orientated

PERSON SPECIFICATION

 

Essential

  • Excellent communication skills
    * Competent third level education in Microsoft packages specifically word, excel and PowerPoint
    * Good organizational skills
    * Flexibility
    * Results orientated
    * Ability to make decisions
    * Minimum of B.Sc. Degree or equivalent.
    * Minimum of 3 years experience in a quality or production function within the pharmaceutical/medical devices industry.
    * To be proactive and improvement driven.

Desirable

 

  • Problem Solving
    * Previous experience leading people
    * Previous experience in auditing

 

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

Find Us
Location
Ireland

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