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QA Document Controller

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Job ID R0039196 Date posted 06/08/2021 Location Dublin, Ireland

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Job Description

JOB PURPOSE:

The Document Controller has a pivotal role to play in the management of Quality System documentation for the Cell Therapy facility at Takeda Ireland Limited Grange Castle (TILGC). A robust document control system is the foundation of a compliant, efficient quality system. Consequently, while the position is primarily administrative, it demands a strong quality focus and attention to detail.  The person is required to take on responsibility for their area of work and to work independently following company SOPs. The role will primarily liaise and support the Cell Therapy Manufacturing facility and supporting functions at TILGC.  Flexibility is important and responsibilities may change or other duties may arise for this position

RESPONSIBILITIES:

  • Manage the preparation, issue and control of GMP documents in the Document Management System (DMS) ensuring that required standards of presentation and formatting are consistently achieved.  Good knowledge of Microsoft Word is required for this work.  
  • Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. 
  • Perform the Business System Administration role in the documentation management system.
  • Ensure that all document training is carried out as required. 
  • Produce monthly key performance indicator (KPIs) on document control systems as required.
  • Maintain document control software packages including; controlled documents database.
  • Develop and maintain the document archiving system.
  • Scan and photocopying of controlled documents.
  • Provision of training to TILGC personnel and contract personnel as directed by the Quality Systems Executive
  • Assist implementation of global standards and procedures into the site Quality Systems.
  • To actively support the development/implementation and continuous improvement of the Document Management System and supporting systems.
  • Provide support for regulatory submissions through collation and compilation of documents for inclusion in filings or presentation to auditors as required. 
  • Be a key member of the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.

GENERAL RESPONSIBILITIES: 

  • Participate fully in any cross functional training initiatives.
  • Drive and promote the corporate values of Takeda-ism within the workplace.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.
  • Ensure timely completion of all SOP, reading, training and assessment.
  • Participate in other projects as directed by the Quality Systems & Compliance Manager

EDUCATIONAL REQUIREMENTS:  

  • Bachelor's degree in chemistry, biology or a related scientific discipline.

RELEVANT EXPERIENCE:

  • A minimum of 4 years working within quality in the pharmaceutical industry.
  • Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
  • Thorough understanding of quality systems and cGMP's.

SKILLS/COMPETENCIES:

  • Excellent verbal and written communication skills.
  • Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
  • Work directly with other key departments to ensure compliance and productive working relationships.

Locations

Grange Castle, Ireland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job ID R0039196
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